Fluid preparation and treatment devices methods and systems

ABSTRACT

Methods, device, and systems for preparing peritoneal dialysis fluid and/or administering a peritoneal dialysis treatment are disclosed. In embodiments, peritoneal dialysis fluid is prepared at a point of use automatically using a daily sterile disposable fluid circuit and one or more long-term concentrate containers that are changed only after multiple days (e.g. weekly). The daily disposable may have concentrate containers that are initially empty and are filled from the long-term concentrate containers once per day at the beginning of a treatment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application62/636,404, filed Feb. 28, 2018 and of U.S. Provisional Application62/676,098, filed on May 24, 2018, all of which are hereby incorporatedby reference in their entireties.

BACKGROUND

The disclosed subject matter relates generally to the treatment of endstage renal failure and more specifically to devices, methods, systems,improvements, and components for performing peritoneal dialysis.

Peritoneal dialysis is a mature technology that has been in use for manyyears. It is one of two common forms of dialysis, the other beinghemodialysis, which uses an artificial membrane to directly cleanse theblood of a renal patient. Peritoneal dialysis employs the naturalmembrane of the peritoneum to permit the removal of excess water andtoxins from the blood.

In peritoneal dialysis, sterile peritoneal dialysis fluid is infusedinto a patient's peritoneal cavity using a catheter that has beeninserted through the abdominal wall. The fluid remains in the peritonealcavity for a dwell period. Osmotic exchange with the patient's bloodoccurs across the peritoneal membrane, removing urea and other toxinsand excess water from the blood. Ions that need to be regulated are alsoexchanged across the membrane. The removal of excess water results in ahigher volume of fluid being removed from the patient than is infused.The net excess is called ultrafiltrate, and the process of removal iscalled ultrafiltration. After the dwell time, the dialysis fluid isremoved from the body cavity through the catheter.

Peritoneal dialysis requires the maintenance of strict sterility becauseof the high risk of peritoneal infection.

In one form of peritoneal dialysis, which is sometimes referred to ascycler-assisted peritoneal dialysis, an automated cycler is used toinfuse and drain dialysis fluid. This form of treatment can be doneautomatically at night while the patient sleeps. One of the safetymechanisms for such a treatment is the monitoring by the cycler of thequantity of ultrafiltrate. The cycler performs this monitoring functionby measuring the amount of fluid infused and the amount removed tocompute the net fluid removal.

The treatment sequence usually begins with an initial drain cycle toempty the peritoneal cavity of spent dialysis fluid, except on so-called“dry days” when the patient begins automated treatment without theperitoneal cavity filled with dialysis fluid. The cycler then performs aseries of fill, dwell, and drain cycles, typically finishing with a fillcycle.

The fill cycle presents a risk of over-filling or over-pressurizing theperitoneal cavity, which has a low tolerance for excess pressure. Intraditional peritoneal dialysis, a dialysis fluid container is elevatedto certain level above the patient's abdomen so that the fill pressureis determined by the height difference. Automated systems sometimesemploy pumps that cannot generate a pressure beyond a certain level, butthis system is not foolproof since a fluid column height can arise dueto a patient-cycler level difference and cause an overpressure. Areverse height difference can also introduce an error in the fluidbalance calculation as a result of incomplete draining.

Modern cyclers may fill by regulating fill volume during each cycle. Thevolume may be entered into a controller based on a prescription. Theprescription, which also determines the composition of the dialysisfluid, may be based upon the patient's size, weight, and other criteria.Due to errors, prescriptions may be incorrect or imperfectly implementedresulting in a detriment to patient well-being and health.

SUMMARY

Embodiments of peritoneal dialysis systems, devices, and methods aredescribed herein. The features, in some cases, relate to automatedperitoneal dialysis and in particular to systems, methods, and devicesthat prepare peritoneal dialysis fluid in a safe and automated way at apoint of care. Other features relate to the precision, safety, and easeof use of such systems.

Objects and advantages of embodiments of the disclosed subject matterwill become apparent from the following description when considered inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D show peritoneal dialysis fluid proportioner/cyclersaccording to respective embodiments of the disclosed subject matter.

FIG. 1E shows a series testable filter arrangement that may besubstituted for the filters employed in the embodiments of FIGS. 1A-1D.

FIGS. 1F-1H show embodiments similar to those of FIGS. 1A-1D andelaborating further details thereof.

FIG. 2A shows a disposable fluid circuit for use with peritonealdialysis fluid proportioner/cyclers of certain embodiments disclosedherein.

FIG. 2B shows an actuator portion of a peritoneal dialysis fluidproportioner/cycler, according to embodiments of the disclosed subjectmatter.

FIG. 2C shows a connection platform between a purified water source andthe peritoneal dialysis fluid proportioner/cycler, according toembodiments of the disclosed subject matter.

FIG. 2D shows a peristaltic pumping actuator that permits the use of astraight pumping tube segment in a generally planar cartridge, employedas a feature of embodiments disclosed herein.

FIG. 2E shows a disposable fluid circuit for a peritoneal dialysis fluidproportioner/cycler according to embodiment of the disclosed subjectmatter in which concentrates are extracted from a disposable componentthat is separate from the cycler/preparation fluid circuit.

FIGS. 2F and 2G show concentrate disposable components for use withembodiments of the disclosed subject matter.

FIG. 2H shows a disposable fluid circuit for a peritoneal dialysis fluidproportioner/cycler according to embodiments of the disclosed subjectmatter in which concentrates are extracted from a disposable componentthat is separate from the cycler/preparation fluid circuit throughrespective filtered lines.

FIGS. 2I, 2J, and 2K show respective embodiments of connection platformsbetween a purified water source and a separate concentrate source andthe peritoneal dialysis fluid proportioner/cycler embodiments disclosedherein, according to embodiments of the disclosed subject matter.

FIGS. 2L and 2M show details of variations of the embodiments describedwith reference to FIG. 2K.

FIG. 3 shows a method of manufacturing a disposable circuit such as isdisclosed in FIG. 2A.

FIG. 4A shows a peritoneal dialysis fluid proportioner/cycler accordingto embodiments of the disclosed subject matter.

FIG. 4B shows the peritoneal dialysis fluid proportioner/cycler of FIG.4A in a first phase of fluid preparation in which osmotic agentconcentrate is added to a mixing container, according to embodiments ofthe disclosed subject matter.

FIG. 4C shows the peritoneal dialysis fluid proportioner/cycler of FIG.4A in a second phase of fluid preparation in which a dialysis fluidprecursor is obtained by diluting and mixing the contents of the mixingcontainer, according to embodiments of the disclosed subject matter.

FIG. 4D shows the peritoneal dialysis fluid proportioner/cycler of FIG.4A in a third phase of fluid preparation in which the peritonealdialysis fluid precursor properties are verified, according toembodiments of the disclosed subject matter.

FIG. 4E shows the peritoneal dialysis fluid proportioner/cycler of FIG.4A in a fourth phase of fluid preparation in which dialysis fluidprecursor is further prepared by addition of electrolyte concentrate tothe mixing container, according to embodiments of the disclosed subjectmatter.

FIG. 4F shows the peritoneal dialysis fluid proportioner/cycler of FIG.4A in a fifth phase of fluid preparation in which end-use dialysis fluidis prepared by adjustment of the dilution of the mixing containercontents, according to embodiments of the disclosed subject matter.

FIG. 4G shows the peritoneal dialysis fluid proportioner/cycler of FIG.4A in a sixth phase of fluid preparation in which dialysis fluid in themixing container is verified, according to embodiments of the disclosedsubject matter.

FIG. 4H and FIG. 4K show the peritoneal dialysis fluidproportioner/cycler of FIG. 4A in various peritoneal dialysis treatmentmodes, according to embodiments of the disclosed subject matter.

FIG. 4L shows a peritoneal dialysis fluid proportioner/cycler similar tothat of FIG. 4A in which a single mixing container line connects a valvenetwork to the mixing container.

FIGS. 5A-5D illustrate the structure and use of a multifunctionconnector according to embodiments of the disclosed subject matter.

FIG. 5E shows features for a variation of a double connector 500 thatprotects against contamination.

FIG. 6A shows mechanical aspects and a control and sensor system for thecut-and-seal devices with actuation, temperature, and force controlfeatures, according to embodiments of the disclosed subject matter.

FIGS. 6B through 6G show various embodiments of cut-and-seal devices.

FIGS. 7A through 7D show various jaw arrangements for cut-and-sealdevices according to different embodiments of the disclosed subjectmatter.

FIGS. 8A and 8B show details of chamber portions of fluid circuitsaccording to embodiments of the disclosed subject matter.

FIGS. 8C through 8G show various features to promote mixing of fluids ina mixing container according to embodiments of the disclosed subjectmatter.

FIG. 9A shows a manifold according to embodiments of the disclosedsubject matter.

FIG. 9B shows a peritoneal dialysis fill/drain line according toembodiments of the disclosed subject matter.

FIGS. 10A and 10B show the structure of a valve network portion of afluid circuit according to embodiments of the disclosed subject matter.

FIG. 11 shows a fluid circuit for peritoneal dialysis according toembodiments of the disclosed subject matter.

FIG. 12 shows a method of priming a fluid circuit according toembodiments of the disclosed subject matter.

FIGS. 13A and 13B show embodiments of a fluid circuit with sources ofconcentrate where different compositions are provided for priming.

FIG. 14 shows a block diagram of an example computer system according toembodiments of the disclosed subject matter.

FIGS. 15A and 15B illustrate a mixing method according to embodiments ofthe disclosed subject matter.

FIG. 15C illustrates an optimization point for a mixing method accordingto embodiments of the disclosed subject matter.

FIG. 15D illustrates a mixing method different from that of FIG. 15Aaccording to further embodiments of the disclosed subject matter.

FIG. 15E is a flow chart in outline form for conductivity error recoveryfor various mixing methods described herein.

FIGS. 16A through 16C are flow diagrams describing a method for mixing amedicament in which electrolyte concentrate is added first to a mixingcontainer according to embodiments of the disclosed subject matter.

FIGS. 17A through 17D show embodiments of proportioning/treatmentsystems in which long-term, multi-treatment containers of concentrateare used to form a ready-to-use peritoneal dialysis fluid according toembodiments of the disclosed subject matter.

FIG. 18A shows an embodiment of a proportioning/treatment system inwhich long-term, multi-treatment containers of concentrate are used tofill a disposable used during a treatment to form a ready-to-useperitoneal dialysis fluid according to embodiments of the disclosedsubject matter.

FIG. 18B-18D show a single flow chart when linked together to define aprocess for making a batch of dialysis fluid based on the embodiment ofFIG. 18A.

FIGS. 18E through 18H show variations of details of the embodiment ofFIG. 18A for supplying concentrate or water to the fluid circuitaccording to embodiments of the disclosed subject matter.

FIG. 19A through 19C describe a first device and corresponding method ofcontrolling the supply of water to a peritoneal dialysis fluid treatmentdevice, according to embodiments of the disclosed subject matter.

FIG. 19D through 19F describe a second device and corresponding methodof controlling the supply of water to a peritoneal dialysis fluidtreatment device, according to embodiments of the disclosed subjectmatter.

FIGS. 19G through 19H and 19J describe a third device and correspondingmethod of controlling the supply of water to a peritoneal dialysis fluidtreatment device, according to embodiments of the disclosed subjectmatter.

FIGS. 19K through 19M describe a fourth device and corresponding methodof controlling the supply of water to a peritoneal dialysis fluidtreatment device, according to embodiments of the disclosed subjectmatter.

FIGS. 20A through 20E show mechanisms for providing sterile filtrationin the various peritoneal proportioning/treatment systems of the variousdisclosed embodiments.

FIG. 20F shows a device for measuring conductivity with minimal loss offluid by locating a conductivity cell in the disposable at a point wherefluid exits the mixing container, according to embodiments of thedisclosed subject matter.

FIG. 20G shows a system and method that may be applied to any of theembodiments in which a pressure sensor used for flow control provides anadditional function of pressure testing of a filter membrane by openinga particular set of valves that define a path from the fluid side of thefilter to the pressure sensor.

FIGS. 21A through 21C show a flow chart for making and correcting errorsin water and concentrate mixtures according to embodiments of thedisclosed subject matter.

FIGS. 22A and 22B show a water filtration system with flushing andpriming modes controlled by a controller which is commanded by a cyclercontroller according to embodiments of the disclosed subject matter withFIGS. 22A and 22B showing production with flushable filters.

FIG. 22C shows multiple additional features that may be added to formvariations of the various embodiments disclosed herein, including thoseof FIGS. 22A and 22B.

FIG. 23 shows an embodiment of a proportioning and treatment system inwhich sampling of spent dialysate is supplemented by a mechanism toallow for the sampling and testing of spent dialysate aliquots ratherthan a full treatment volume of spent dialysate.

FIG. 24 shows a peritoneal dialysis system connected to a remote devicefor purposes of describing various features that may be used with thedisclosed embodiments to form additional disclosed embodiments.

FIG. 25 shows a flow chart for describing an embodiment based on thepremise that discrepancies between a measured conductivity and theexpected conductivity result from a reduction in moisture content of oneor both of the pre-packaged concentrates, such as may result frommoisture loss due to evaporation, according to embodiments of thedisclosed subject matter.

FIGS. 26A through 26C illustrate a system and method for using aproportioning system to infuse a medicament with a drug or othersubstance.

Embodiments will hereinafter be described in detail below with referenceto the accompanying drawings, wherein like reference numerals representlike elements. The accompanying drawings have not necessarily been drawnto scale. Where applicable, some features may not be illustrated toassist in the description of underlying features.

DETAILED DESCRIPTION

FIGS. 1A-1D show peritoneal dialysis fluid proportioner/cyclersaccording to respective embodiments of the disclosed subject matter.Referring now to FIG. 1A, medical fluid preparation and peritonealdialysis fluid proportioner/cycler system 90A includes a purified watersource 104 that provides water suitable for peritoneal dialysis to aperitoneal dialysis fluid proportioner/cycler 103 which is connected toa disposable component 100A. The purified water source 104 also providesa connection to a drain (shown in FIG. 1A only, but similar in FIGS.1B-1D). The peritoneal dialysis fluid proportioner/cycler 103 metersconcentrate from one or more concentrate containers 101 (one containeris shown but multiple containers may be present) and adds them to, anddilutes them with purified water in a mixing container 102. Theconcentrate containers 101 and mixing container 102 form parts of asingle disposable which may also contain a switchable fluid circuit (notshown) that forms part of the disposable component 100A. Mixed dialysisfluid (or other medicament) is pumped by the peritoneal dialysis fluidproportioner/cycler 103 through a connected line to a patient 101A, forexample for peritoneal dialysis. The configuration of FIG. 1A allows thesterile concentrate and the fluid circuit and containers used forpreparation, as well as short term storage, to be provided as a singlesealed sterile disposable with a small predefined number of connectionsto external devices. These may include connections to the purified watersource 104 and connections to the external medicament consumer. Thesmall number of connections minimizes the risk of contamination. Bydiluting and mixing concentrate at the point of use, the volume of fluidthat has to be stored at a peritoneal dialysis treatment location isalso minimized. In a peritoneal dialysis embodiment, the disposablecomponent 100A may be configured with sufficient concentrate to performmultiple fill/drain cycles of a single peritoneal dialysis treatment.For example, the disposable component 100A may have sufficientconcentrate for multiple fill cycles of a daily automated peritonealdialysis treatment (APD).

Referring now to FIG. 1B, a medical preparation and peritoneal dialysisfluid proportioner/cycler system 90B is similar to the medical fluidpreparation and peritoneal dialysis fluid proportioner/cycler system 90Aexcept that the disposable component 100B that has a fluid circuit forproportioning and diluting as well as delivering the product medicamentdoes not contain the concentrate. This allows the size of the disposablecomponent 100B, which is handled frequently, for example, daily, to bereduced in mass and easier for a patient and/or user to handle andstore. It also can make the disposable component 100B more economical byreducing waste and providing packaging and manufacturing economies. Toprovide the concentrate, a separate disposable component 100E isprovided which contains one or more concentrate containers 101. Thedisposable component 100E may have a large capacity and may be changedon a schedule that is much less frequent than the frequency of thereplacement of the disposable component 100B. For example, thedisposable component 100B may be replaced each time a daily peritonealdialysis treatment is performed. It may be called a “daily disposablecomponent.” For example, the disposable component 100E may be replacedonce every month so it may be called a “monthly disposable” or it may bereplaced every week and called a “weekly disposable”. The precisecapacity and the time the disposable generally lasts is not a limitingfeature of the disclosed subject matter. What is relevant is that thedisposable component 100E (and others disclosed below) have sufficientcapacity for multiple treatments where each treatment includes multiplefill/drain cycles of a peritoneal dialysis treatment.

The disposable component 100B may also have, as part of the fluidcircuit included therein, a sterilizing filter 115 of a type that has anair-line 118 to permit the pressure testing of a membrane thereof. Thelatter type of filter test may be performed automatically by acontroller of the peritoneal dialysis fluid proportioner/cycler 103 on aschedule that is more frequent than the replacement schedule for thedisposable component 100E. In embodiments, the sterilizing filter 115may be integrated, and therefore, replaced with, the disposablecomponent 100B. This allows the sterilizing filter 115 to be sealed andsterilized with the disposable component 100B and mixing container 102as a single unit along with the switchable fluid circuit (not shown).Note details of a suitable configuration for a switchable fluid circuitmay be found in International Patent Application PublicationWO2013141896 to Burbank, et al.

A function provided by the sterilizing filter 115 is to provide safetygiven that a new sterile disposable component 100B is attached to theconcentrate 101 for each peritoneal dialysis treatment. A similar filtermay be employed in all the embodiments for the line indicated at 107conveying the purified water to the peritoneal dialysis fluidproportioner/cycler 103. Since a new connection is required each timethe disposable component 100B is replaced, there is a risk ofcontamination from the new connection. The sterilizing filter 115 (andothers) can be provided as a sterile barrier to protect the sterileinterior of the disposable component 100B, thereby ensuring that anycontamination resulting from the newly-made connection does not enterthe disposable component 100B interior. In addition, the automatictesting of the filter provides assurance that the sterilizing filter 115integrity has provided the expected sterile fluid. Thus, the testabilityfunctions as a guarantee of the filter's sterilizing function. Testingof sterilizing filters using pressurized air testing can be done invarious ways, for example, a bubble point test can be performed.Alternatively, a pressure decay test can be done where fluid is pumpedacross the membrane and the pressure drop measured and compared with apressure drop representative of an intact filter or pressure isincreased on one side, pumping stopped, and the rate of decay ofpressure compared to a predefined curve representative of an intactfilter. In other embodiments, the filter is housed in an air-tightcontainer and the container is pressurized to a level that is below theexpected bubble point, but high enough to guarantee that the membrane issterilizing grade. The filter has air vents so this pressurizes themembrane. The rate of (air) pressure decay is then measured and if thedecay rate is greater than a predefined threshold rate, the filter isindicated to have failed. Other means of testing filter integrity may beused, for example, concentrates can include a large-molecule excipientwhose presence can be detected using automatic chip-based analytedetection (e.g., attachment of fluid samples to selective fluorophoreafter flowing through the filter and optical detection afterconcentration). A feature of the embodiments that use a filter toprovide the guarantee, as mentioned, is that the filter forms part of asterilized unit that is otherwise hermetically sealed or protected byone or more additional sterilizing filters. Thus, in embodiments, theentire sealed and sterilized circuit may have sterilizing filters (1) atall openings to its interior or at least (2) at all openings to whichfluid is admitted from the external environment.

Referring now to FIG. 1C, a medical preparation and peritoneal dialysisfluid proportioner/cycler system 90C is similar to the medical fluidpreparation and peritoneal dialysis fluid proportioner/cycler system 90Bin that the disposable component 100C that has a fluid circuit forproportioning and diluting as well as delivering the product medicamentdoes not contain the concentrate. As in peritoneal dialysis fluidproportioner/cycler system 90B, a separate disposable component 100F isprovided which contains one or more concentrate containers 101, in thisexample, a first concentrate container 105A and a second concentratecontainer 105B are shown. These may be in the form of canisters held bya single packaging wrapper 105C or they may be replaced separately whenthey expire or are exhausted. As in the peritoneal dialysis fluidproportioner/cycler system 90B, the disposable component 100C may have alarge capacity and may be changed on a schedule that is much lessfrequent than the frequency of the replacement of the disposablecomponent 100B. For example, the first concentrate container 105A and/orsecond concentrate container 105B may be sized to be replaced on amonthly basis. In the medical fluid preparation and peritoneal dialysisfluid proportioner/cycler system 90C, the disposable component 100C mayalso have, as part of the fluid circuit included therein, twosterilizing filters (collectively indicated as the sterilizing filter115), each of the type that has an air-line 118 to permit thepressure-testing of a membrane thereof. Each of the concentrates fromfirst concentrate container 105A and second concentrate container 105Bmay thereby be sterile-filtered and the filter tested for eachseparately. As in the peritoneal dialysis fluid proportioner/cyclersystem 90B, this configuration allows the sterilizing filters 115 to besealed and sterilized with the disposable component 100C and mixingcontainer 102 as a single unit along with the switchable fluid circuit(not shown). As in any of the embodiments a sterilizing filter may beused in the water line as indicated at 107.

Referring now to FIG. 1D, a medical preparation and peritoneal dialysisfluid proportioner/cycler system 90D is similar to the medical fluidpreparation and peritoneal dialysis fluid proportioner/cycler system 90Cin that the disposable component 100C that has a fluid circuit forproportioning and diluting as well as delivering the product medicamentdoes not contain the concentrate. As in peritoneal dialysis fluidproportioner/cycler system 90C, a separate disposable component 100G isprovided which contains a first concentrate container 105A and a secondconcentrate container 105B. As in any of the embodiments, the number ofconcentrates may be greater or fewer. The concentrates may be held inthe canisters which may have a single packaging wrapper 105C or they maybe replaced separately when they expire. As in the peritoneal dialysisfluid proportioner/cycler system 90C, the disposable component 100G mayhave a large capacity such that it can be replaced on a schedule that ismuch less frequent than the frequency of the replacement of thedisposable component 100D. For example, the first concentrate container105A and/or second concentrate container 105B may be sized to bereplaced on a monthly basis. In the medical fluid preparation andperitoneal dialysis fluid proportioner/cycler system 90D, the disposablecomponent 100D may also have, as part of the fluid circuit includedtherein, the sterilizing filter 115, also of the type that has anair-line 118 to permit the pressure testing of a membrane thereof. Tosterile-filter each of the concentrates from first concentrate container105A and second concentrate container 105B, a connection platform allowsthe peritoneal dialysis fluid proportioner/cycler 103 to draw purifiedwater, first concentrate container 105A or second concentrate container105B selectively by closing a valve on all but one of these at a time bythe connection platform 106 under control of the peritoneal dialysisfluid proportioner/cycler 103. As in the peritoneal dialysis fluidproportioner/cycler system 90B, this configuration allows thesterilizing filter 115 to be sealed and sterilized with the disposablecomponent 100D and mixing container 102 as a single unit along with theswitchable fluid circuit (not shown). The switching fluid circuit of theconnection platform 106 may be part of a disposable that is replacedwith the first concentrate container 105A and second concentratecontainer 105B.

In the present and any of the embodiments, the long-term concentratecontainers (e.g., monthly disposable) may be replaced on separateschedules so they need not be packaged as a single disposable. This mayprovide further economy when one concentrate is used at a lower rate bysome patients than others, thus allowing the concentrate to be consumedfully before replacing.

It should be evident that there is the potential for the reduction ofwaste of concentrate by structuring the batch preparation components topermit the changing of concentrates independently of each other and atintervals that cover multiple peritoneal dialysis treatment sessions.Each concentrate container can be used until exhaustion. Forembodiments, exhaustion may be defined to be a condition whereinsufficient concentrate remains in a single container to permit thepreparation of a full batch of peritoneal dialysis fluid, a full batch,in embodiments, being a quantity of concentrate component sufficient fora single fill cycle. In other embodiments, a concentrate container maybe exhausted when there is insufficient concentrate to make a predefinednumber of batches or enough to make sufficient dialysate for a fulltreatment. If two concentrates are mixed to form a batch, each componentconcentrate may be changed out when the prescription's requiredcontribution of that concentrate to make a single batch exceeds theremaining volume in the particular container. The residual volumethreshold associated with this insufficiency is a fixed volume, so thatits percentage of the total volume available from a full container issmaller for a large container than for a smaller container. Thus, inembodiments where the concentrate container is replaced only when thethreshold is reached, which container holds large total volume, forexample, enough for multiple fill cycles, or better, enough for multipleperitoneal dialysis treatments each including multiple fill cycles, thetotal waste is much smaller than a disposable component containingconcentrate for a single peritoneal dialysis treatment. An example ofthe latter is discussed below with reference to FIGS. 8A and 8B. Inaddition, since each concentrate container can be replaced separately,the fixed residual thresholds of the multiple concentrate containers areindependent of each other because each container can be replacedindependently of the other. In contrast, in the embodiments of FIGS. 8Aand 8B, if one container reaches the minimum volume before the other,the contents of neither concentrate container can be used further.

In embodiments, the concentrate containers are sized to permit a singleperitoneal dialysis treatment. For convenience and convention, a singleperitoneal dialysis treatment would be considered a single day's worthof peritoneal dialysis treatment, for example, a series of nocturnal PDcycles ending with a fill. So, a single day's peritoneal dialysistreatment is equal to a sufficient quantity of fluid to perform multiplefill and drain cycles. Embodiments in which the concentrate containersare sized for a single day's peritoneal dialysis treatment differ fromthose described with reference to the embodiments of FIGS. 8A and 8B inthat the concentrates can be changed independently thereby achieving apotential savings of a first concentrate that is used at a rate suchthat a residual volume of the first concentrate can be used more fullyas described above. More specifically, if the concentrate containers aresized such that batches of at least predefined prescriptions requiremore of a first concentrate component than of a second concentratecomponent and such that at least one batch, or at least one day's worthof batches can be completed while leaving sufficient residualconcentrate of the second component to make at least one additionalbatch, or one additional day's worth of batches, after replacing thefirst concentrate component, then a savings of the second concentratemay be enjoyed. In embodiments, the total concentrate of the mostheavily used container of a multiple-component concentrate system is atleast sufficient for:

Multiple batches, a batch being sufficient for a single peritoneal cycle(fill volume of a peritoneum of a predefined class of patient (e.g.,child, adult, adult of a certain size, etc.);

Same as 1, but where the multiple batches are sufficient for a singleperitoneal dialysis treatment of multiple fill-drain cycles;

Same as 2, but the most heavily used concentrate container is sufficientfor making enough dialysis fluid for multiple peritoneal dialysistreatments;

Same as 2, but the most heavily used concentrate container is sufficientfor making enough dialysis fluid for multiple days' worth of peritonealdialysis treatments if a single day's worth is not identical to a singleperitoneal dialysis treatment's worth;

A full week's worth of peritoneal dialysis treatments; or

A full month's worth of peritoneal dialysis treatments or some otherinterval on the order of a month or multiple months.

FIGS. 1F-1H show embodiments similar to those of FIGS. 1A-1D andelaborating further details thereof. Referring now to FIG. 1F, a fluidcircuit is indicated at 112. The fluid circuit 112 engages with theperitoneal dialysis fluid proportioner/cycler 114 by means of valveactuators 123 and one or more pumping actuators 125 which engage thefluid circuit elements of the fluid circuit 112 without wetting theactuator components. For example, a type of valve actuator such as alinear-motor driven pinch clamp may close and open tubing for flowtherethrough and peristaltic pump rollers may engage pumping tubesegments. The configuration is not limited to such examples, and manyare known in the art, any of which may be used in the presentembodiment. The fluid circuit 112 has water suitable for peritonealdialysis and drain lines 126, 127. The water suitable for peritonealdialysis flows through a line with a sterilizing filter 115 according toany of the disclosed embodiments including a testable filter and twosterilizing filters in series. The only connections that need to be madefor supplying fluid or draining fluid are connections indicated at 129.The water suitable for peritoneal dialysis and drain lines 126, 127 maybe formed as part of the fluid circuit 112. In embodiments, the fluidcircuit 112, concentrate container(s) 101, and mixing container 102 maybe pre-connected to form a complete disposable fluid circuit 100Aincluding concentrate.

Referring now to FIG. 1G, further details of the peritoneal dialysisfluid proportioner/cycler system 90C are shown. The separate disposablecomponent 100F contains concentrate containers 105A and 105B andconnects to the peritoneal dialysis fluid proportioner/cycler 114 byconnectors 121, which may include a double connector as described inembodiments described herein or other types. The peritoneal dialysisfluid proportioner/cycler 114 has pumping actuators 125 and valveactuators 123 that engage the fluid circuit 112. Here the peritonealdialysis fluid proportioner/cycler 114 provides a pass-throughconnection for the concentrate while the sterilizing filters 115 on theconcentrate lines 130 form part of the disposable component 100C, whichincludes the fluid circuit 112 and mixing container 102. That is, theperitoneal dialysis fluid proportioner/cycler 114 connects theconcentrate lines 131 respectively to the concentrate lines 155A and155B of the fluid circuit 112. Here also, connectors for air-lines 130Aand 130B are provided to the peritoneal dialysis fluidproportioner/cycler 114 where an air pump (not shown) can generate apositive pressure and a pressure sensor can measure the positivepressure. A filter integrity test may be done after flowing fluid intothe fluid circuit. During set-up, the disposable component 100C may beconnected by connecting water suitable for peritoneal dialysis and drainlines 116, 117, concentrate lines 155A and 155B and air-lines 130A and130B, while the connectors 121 can remain in place through the entirelong-term disposable cycle, that is, until the separate disposablecomponent 100F is expired. Since the latter is replaced much lessfrequently, the connectors 121 can remain in place for a relatively longperiod, and frequent changes can be limited to changing connectors 122,120, and connectors for water suitable for peritoneal dialysis and drainlines 116, 117 as well as the air-lines 130A and 130B. In embodiments,for convenience, all of these connections can be provided in the form ofganged connectors to make and unmake multiple connections at once. Theconcentrate containers 105A and 105B may connect to a connectionplatform (not shown as a unit but may include the connectors and asupport for the concentrate containers 105A and 105B) and a holder forthe by the peritoneal dialysis fluid proportioner/cycler 114. Seefurther connection platform embodiments for details.

Referring to FIG. 1H, a simplified arrangement becomes possible if thedisposable component 100G is connected to the peritoneal dialysis fluidproportioner/cycler 114 by connectors 121, but all concentrates andwater flow into the fluid circuit 112 via the fluid line 135 and all ofthese fluids are filtered by sterilizing filter 115. To provide this, aconnection platform with its own controller (not shown separately) maybe provided and connected to a peritoneal dialysis fluidproportioner/cycler, the combination being illustrated at 119. Theconnection platform portion of the combined peritoneal dialysis fluidproportioner/cycler and connection platform 119 may be as described withreference to FIGS. 2K through 2M, for example. The connection platformportion of the combined peritoneal dialysis fluid proportioner/cyclerand connection platform 119 selects one of the fluids at a given time byclosing off the others and opening a fluid path to the selected one ofwater, concentrate A, and concentrate B. As indicated, here and in anyembodiments, further or fewer concentrates may be used. A drain line 135is present. A communications interface may be provided to allow commandsto be sent from the fluid circuit 112 to the peritoneal dialysis fluidproportioner/cycler and connection platform 119.

FIG. 2A shows a disposable fluid circuit 200 with fluid lines andcomponents 200A and a cartridge portion 205 containing a fluid flowdirector portion 200B and a manifold portion 200E. The disposable fluidcircuit 200 is used as a replaceable disposable component with aperitoneal dialysis fluid proportioner/cycler according to embodimentsdisclosed herein. The present disposable fluid circuit 200 may be usedwith the peritoneal dialysis fluid proportioner/cycler system 90A, forexample. Two concentrate containers 111A and 111B and a mixing container102 are connected as a pre-connected unit with other parts of the fluidcircuit. The two concentrate containers 111A and 111B and mixingcontainer 102 may be provided as a welded double panel sheet with weldedseams that define the respective chambers. The mixing container 102 hastwo lines, an inflow line 165 and an outflow line 166. A firstconcentrate container 111A container has 167, which may be pre-connectedand a second concentrate container 111B line 164, which may bepre-connected. The present embodiment is for a peritoneal dialysis fluidproportioner/cycler and has a pre-connected fill-drain line 160 with adialysis fluid line 172 attached to an air-line 129. The latter may beformed as a single unit by co-extrusion. The air-line 129 attaches to apressure-sensing pod 162 located at a distal end of the pre-connectedfill-drain line 160. A connector 185 at the distal end of thepre-connected fill-drain line 160 is sealed. Another double line 161 hasan air-line 129 and a fluid line 171. The fluid line 171 receives fluidfrom peritoneal dialysis fluid proportioner/cycler 114 and the air-lineis used for testing the membrane of the filter. The two air-lines 129connect to respective ports 191 that automatically connect in theactuator portion 140 of any of the suitable peritoneal dialysis fluidproportioner/cycler embodiments. The actuator portion 140 may be isdescribed with reference to FIG. 2B. Sample ports are provided at 168 atthe ends of sample fluid lines 132 and 133 for extracting fluid fromrespective chambers 175 and 176 of a manifold 174. The two chambers 175and 176 are separated by a barrier 134 and connected by a pumping tubesegment 137. Pressure pods 178 are installed in each of the two chambers175 and 176 to measure pressure on the suction and pressure sides of thepumping tube segment 137. The dialysis fluid line 172 has two branches136 and 139. A waste line 128 and the fluid line 171 connect via adouble connector 181. Lines 132, 128, 165, and branch 136 connect tochamber 175. Lines 133, 164, 166, 167, 171 and branch 139 connect tochamber 176.

The double connector 181 supports lines 171 and 128 and provides a pairof connectors 186 and 187 to permit connection of lines 171 and 128 towater inlet and fluid drain line ports on the peritoneal dialysis fluidproportioner/cycler 114. The connectors 186 and 187 are sealed by a cap180. A recess 5251 (See FIGS. 5A, 5B) to engage a détente pin (notshown, but may be a spring-biased pin in the opening that receives thedouble connector 181) provides tactile confirmation of full engagementof the double connector 181. The double connector 181 has a window 183that provides access to a cut and seal actuator (not shown in thisdrawing but indicated at 210 in FIGS. 2I through 2K). When the segments182 and 184 of lines 171 and 128 are cut, the double connector canremain in place sealing the water inlet and fluid drain line ports untilit is removed immediately prior to connecting a fresh double connector181. This provides a barrier to prevent contaminants from entering thewater inlet and fluid drain line ports, which in turn protects thesterile fluid path used by the peritoneal dialysis fluidproportioner/cycler or connection platform.

The first concentrate container 111A and concentrate container 111B areboth sealed by a frangible seal 154 in each of the lines 164 and 167.The seal is fractured automatically by an actuator after the manifoldcartridge 205 is loaded into a receiver that engages it with theinterface shown in FIG. 1B. Holes 170 are provided in a cartridgesupport 169 that holds the lines in predefined positions. Holes 170provide access to pinch actuators that selectively close and open thelines 177. Certain lines such as lines 177 engage with valve actuatorsso that they function as valve segments. Holes 179 provide access toactuators that fracture the frangible seals 154. Note that the cartridgesupport 169 is bridged to the manifold 174 by a battery of tubesindicated collectively at 200C. Even though the polymer of the tubes isflexible, their lengths, number, are such that the overall structureincluding the cartridge support 169 and the manifold 174 is sufficientlystiff may be readily inserted in a receiving slot.

FIG. 2B shows an actuator portion 140 of a peritoneal dialysis fluidproportioner/cycler, according to embodiments of the disclosed subjectmatter. Referring to FIG. 2B, a receiving slot 158 receives thecartridge portion 205 and aligns it with the various actuators andsensors now identified. The various actuators and sensors include pinchclamp actuators 141 that selectively press against selected tubes toprovide a valve function. The actuators and sensors further includefrangible seal actuators 142 that fracture frangible seals 154 in theconcentrate lines that contain them. The frangible seal actuators 142may be activated simultaneously to open the lines between the pump andthe concentrate containers once the pump (e.g., eight-roller peristalticpump 143—note that the number of rollers can be any number) is engagedwith the pumping tube segment 137. The actuators and sensors furtherinclude an air sensor 150, for example an optical air sensor, that wrapspartly around the tube segment of branch 136 in the upper portion of thehole indicated at 124. Ports 146 and 147 connect a vacuum or pressurepump to the respective ports 191.

FIG. 2C shows connection platform 219 that serves as an interfacebetween a purified water source and the peritoneal dialysis fluidproportioner/cycler, according to embodiments of the disclosed subjectmatter. Connection platform 219 is an embodiment that may provide forconnection to water and drain lines 116 and 117 of embodiments of FIGS.1G and 1H as well as connectors for the concentrate containers 105A and105B for interfacing with the peritoneal dialysis fluidproportioner/cycler 114. The connection platform 219 permits thepurified water source 104 to be connected to different devices, such asdifferent peritoneal dialysis treatment devices. Shown here is aconfiguration adapted for peritoneal dialysis medicament preparation,and optionally peritoneal dialysis treatment also.

Water from the purified water source 104 is received in water line 245via connection 244 and flows through ultrafilters 237. Pressure of thewater suitable for peritoneal dialysis supply is monitored by a pressuresensor 218. A valve 234 selectively controls the flow of water suitablefor peritoneal dialysis to a double connector 215. The purified watersource terminates at a purified water connector 224 of the doubleconnector 215. The double connector 215 also has a drain terminalconnector 225 which splits at a junction 220 into a path that flows to apair of conductivity sensors 230 and then merges at junction 238 toproceed to a drain 236 and a path that flows directly to the drain 236.The selected path is controlled by valves 232, 240, and 242 which arecontrolled by a controller 210. The double connector 181 previouslydescribed is received in a slot 214 where connections are made to thepurified water connector 224 and drain terminal connector 225. A détentemechanism 216 provides tactile and audible feedback to the operator whena home (fully connected) position of the double connector 181 isrealized by inserting into the receiving slot 214. The receiving slot214A has a cutting and sealing actuator 212 driven by a controller 210that cuts the tubes through the window of double connector 181. Aconnector 239 serves as an adapter to permit connection to various typesof drains. The connection platform 219 is also provided with sensorsincluding a moisture sensor 249 located to detect leaking fluid in theconnection platform 219, a tilt sensor 226 to indicate the properorientation of the connection platform 219, and a user interface tointeract with the controller 210. The connection platform 219 may bereceived in a receiving slot 231 and may be formed as a unitaryreplaceable component. If sterility or leakage problems arise, theconnection platform 219 can be replaced easily.

FIG. 2D shows a peristaltic pumping actuator 143 that permits the use ofa straight pumping tube segment in a generally planar cartridge,employed as a feature of embodiments disclosed herein. The rollers 145are attached to a rotor that has recesses to permit clearance for thebulge of an adjacent pumping tube segment positioned between a race 148and the rollers 145. The rollers 145 are unsprung, unlike otherperistaltic pump rollers, and rotate on fixed bearings 1472. Instead,the race 148 is sprung by springs 144 which urge the race against apumping tube segment pinched by the rollers 145. This is a particularembodiment of a pump and at least some of the embodiments are notlimited based on whether the rollers or race are sprung. Either therotor 149 can be moved toward the race 148 to engage a pumping tubesegment, or the race 148 can be moved toward the rotor 149. A sufficientgap at 1492 during loading allows a cartridge, such as cartridge portion200B with a pumping tube segment to be slid in with no interference. Therace 148 is constrained to tilt (in the plane of the drawing) andtranslate up and down in the plane of the drawing by pins 152 receivedin guides 153.

FIG. 2E shows a disposable fluid circuit for a peritoneal dialysis fluidproportioner/cycler according to an embodiment of the disclosed subjectmatter in which concentrates are extracted from a disposable componentthat is separate from the cycler/preparation fluid circuit. A disposablefluid circuit 300 has fluid lines and components 300A and a cartridgeportion 305 containing a fluid flow director portion 300B and a manifoldportion 300E. The disposable fluid circuit 300 is for use withperitoneal dialysis fluid proportioner/cyclers of certain embodimentsdisclosed herein. The present disposable is an embodiment that may beused with the peritoneal dialysis fluid proportioner/cycler system 90Bor 90D, for example, where two concentrate containers 105A and 105B (notshown in this drawing but shown in FIGS. 1B and 1H—again, only asexamples so other features of the peritoneal dialysis fluidproportioner/cycler are not limiting of the disposable fluid circuit300) are provided as a separate unit from disposable fluid circuit 300,which has a mixing container 102 and no concentrate containers. Themixing container 102 may be provided as a welded double panel sheet withwelded seams that define the chambers. The mixing container 102 may havetwo lines, an inflow line 165 and an outflow line 166. In alternativeembodiments, the mixing container 102 may have only a single line forboth inflow and outflow.

The present embodiment is for a peritoneal dialysis fluidproportioner/cycler and has a pre-connected fill-drain line 160 with adialysis fluid line 172 attached to an air-line 129. The latter may beformed as a single unit by co-extrusion. In alternative embodiments, thefill-drain line may be separate and connectable with a separateconnector. In the present embodiment, the air-line 129 attaches to apressure-sensing pod 162 located at a distal end of the pre-connectedfill-drain line 160. A connector 185 at the distal end of thepre-connected fill-drain line 160 is sealed. Another double line 161 hasan air-line 129 and a fluid line 171. The fluid line 171 receives fluidfrom peritoneal dialysis fluid proportioner/cycler 114 and the air-lineis used for testing the membrane of the filter. The two air-lines 129connect to respective ports 191 that automatically connect in anactuator portion 140 as described with reference to FIG. 2B. Sampleports are provided at 168 at the ends of sample fluid lines 132 and 133for extracting fluid from respective chambers 175 and 176 of a manifold174. The two chambers 175 and 176 are separated by a barrier 134 andconnected by a pumping tube segment 137. Pressure pods 178 are installedin each of the two chambers 175 and 176 to measure pressure on thesuction and pressure sides of the pumping tube segment 137. The dialysisfluid line 172 has two branches 136 and 137. A waste line 128 and thefluid line 171 connect via a double connector 181. Lines 132, 128, 165,and branch 136 connect to chamber 175. Lines 133, 164, 166, 167, 171 andbranch 139 connect to chamber 176.

The double connector 181 supports lines 171 and 128 and provides a pairof connectors 186 and 187 to permit connection of lines 171 and 128 towater inlet and fluid drain line ports on the peritoneal dialysis fluidproportioner/cycler 114. The connectors 186 and 187 are sealed by a cap180. A recess to engage a détente pin provides tactile confirmation offull engagement of the double connector 181. The double connector 181has a window 183 that provides access to a cut and seal actuator (notshown in this drawing). When the segments 182 and 184 of lines 171 and128 are cut, the double connector can remain in place sealing the waterinlet and fluid drain line ports on the peritoneal dialysis fluidproportioner/cycler 114 until it is removed immediately prior toconnecting a fresh double connector 181. This provides a barrier toprevent contaminants from entering the connection platform 219 fluidpath, which in turn protects the sterile fluid path used by theperitoneal dialysis fluid proportioner/cycler 114. The connectionplatform 219 selects the fluid to be delivered to the fluid line 171.Holes 170 are provided in the cartridge support 169 that holds the linesin predefined positions. Holes 170 provide access to pinch actuatorsthat selectively close and open the lines 177. Note that the cartridgesupport 169 is bridged to the manifold 174 by a battery of tubesindicated collectively at 300C. Even though the polymer of the tubes isflexible, the cartridge support 169 and the manifold 174 may be readilyinserted in a receiving slot.

FIGS. 2F and 2G show concentrate disposable components for use withembodiments of the disclosed subject matter. Referring to FIG. 2F, aconcentrate package 206, for example a cardboard box, contains a pair ofconcentrate containers 262 and 264. Each of the concentrate containers262 and 264 may be connected to a respective port 265, 266 of a doubleconnector 181B, the double connector 181B may be as the one describedabove (FIGS. 2A, 2E) or below (e.g., 5A-5E) or another type of connectoror pair of connectors. For example, a simple two-port connector 273 maybe used. Separate connectors may also be used to permit the containersto be replaced independently of each other. In embodiments, the doubleport may be connected to a receiving device 287 as shown in FIG. 2G sothat each concentrate 262 or 264 can be installed in the receivingdevice 287 independently of the other while the double connector 181Bremains connected to the receiving device 287. The receiving device 287has fluid connectors 285 for connecting to corresponding connectors onthe concentrate containers 262 and 264 such that once a respective oneof the containers 262 or 264 is installed, fluid can be drawn throughthe ports 288A and 288B of the two-port connector 273. The latter may beconnected to the connection platform 219, for example as shown in FIG.2I.

FIG. 2H shows a disposable fluid circuit 310 for a peritoneal dialysisfluid proportioner/cycler according to embodiments of the disclosedsubject matter in which concentrates are extracted from a disposablecomponent that is separate from the cycler/preparation fluid circuitthrough respective filtered lines. The disposable fluid circuit 310 hasfluid lines and components 310A and a cartridge portion 315 containing afluid flow director portion 310B and a manifold portion 310E. Thedisposable fluid circuit 310 is for use with peritoneal dialysis fluidproportioner/cyclers of certain embodiments disclosed herein. Thepresent disposable is an embodiment that may be used with the peritonealdialysis fluid proportioner/cycler system 90C where two concentratecontainers 105A and 105B are provided as a separate disposable from oneshown in 100C with a mixing container 102, only. The mixing container102 may be provided as a welded double panel sheet with welded seamsthat define a chamber. The mixing container 102 has two lines, an inflowline 165 and an outflow line 166. The present embodiment is for aperitoneal dialysis fluid proportioner/cycler and has a pre-connectedfill-drain line 160 with a dialysis fluid line 172 attached to anair-line 129. The fill-drain line 160 with a dialysis fluid line 172attached to an air-line 129 may be formed as a single unit byco-extrusion of both lines. The air-line 129 attaches to apressure-sensing pod 162 located at a distal end of the pre-connectedfill-drain line 160. A connector 185 at the distal end of thepre-connected fill-drain line 160 is sealed. Another double line 161 hasan air-line 129 and a fluid line 171. The fluid line 171 receives fluidfrom peritoneal dialysis fluid proportioner/cycler 114 and the air-lineis used for testing the membrane of the filter. The two air-lines 129connect to respective ports 191 that automatically connect in anactuator portion such as 140 as described with reference to FIG. 2B (see146 and 147 of FIG. 2B). Sample ports are provided at 168 at the ends ofsample fluid lines 132 and 133 for extracting fluid from respectivechambers 175 and 176 of a manifold 174. The two chambers 175 and 176 areseparated by a barrier 134 and connected by a pumping tube segment 137.Pressure pods 178 are installed in each of the two chambers 175 and 176to measure pressure on the suction and pressure sides of the pumpingtube segment 137. The dialysis fluid line 172 has two branches 136 and139. A waste line 128 and the fluid line 171 connect via a doubleconnector 181. Lines 132, 128, 165, and branch 136 connect to chamber175. Lines 133, 164, 166, 167, 171 and branch 139 connect to chamber176. The fluid line 171 connects to a water source.

The double connector 181 supports lines 171 and 128 and provides a pairof connectors 186 and 187 to permit connection of lines 171 and 128 towater inlet and fluid drain line ports on the peritoneal dialysis fluidproportioner/cycler 114. The connectors 186 and 187 are sealed by a cap180. A recess to engage a détente pin provides tactile confirmation offull engagement of the double connector 181. The double connector 181has a window 183 that provides access to a cut and seal actuator (notshown in this drawing). When the segments 182 and 184 of lines 171 and128 are cut, the double connector can remain in place sealing the waterinlet and fluid drain line ports on the peritoneal dialysis fluidproportioner/cycler 114 until it is removed immediately prior toconnecting a fresh double connector 181. This provides a barrier toprevent contaminants from entering the connection platform fluid path,which in turn protects the sterile fluid path used by the peritonealdialysis fluid proportioner/cycler 114. The connection platform 219selects the fluid to be delivered to the fluid line 171. Holes 170 areprovided in a cartridge support 169 (which may be vacuum-formed) thatholds the lines in predefined positions. Holes 170 provide access topinch actuators that selectively close and open the lines 177. Note thatthe cartridge support 169 is bridged to the manifold 174 by a battery oftubes indicated collectively at 310C. Even though the polymer of thetubes is flexible, the cartridge support 169 and the manifold 174 may bereadily inserted in a receiving slot. Two concentrates are receivedthrough lines 164 and 167, respectively. Each of the lines is filteredby a filter 115 as described with reference to FIG. 1G. Respective holes170 are provided to control the flow of concentrate through each of thelines 164 and 167. FIGS. 2I and 2J show examples of connection platforms219 for connecting to a double connector 181A to permit concentrate tobe drawn through the lines 164 and 167.

Note that the actuators and sensors of the embodiments of FIGS. 2I, 2J,2K, 2L, and 2M may be controlled by a single controller, for example.

FIGS. 2I, 2J, and 2K show respective embodiments of connection platformsthat interface between a purified water source and a separateconcentrate source and the peritoneal dialysis fluid proportioner/cyclerembodiments disclosed herein, according to embodiments of the disclosedsubject matter. Referring now to FIG. 2I and connection platform 219 isan embodiment of the interface providing the water supply and drainconnections (116, 117, See FIGS. 1G and 1H) between the purified watersource 104 and the peritoneal dialysis fluid proportioner/cycler 114.The connection platform 219 permits the purified water source 104 (FIGS.1F-1G) to be connected to different devices, such as differentperitoneal dialysis treatment devices. Shown here is a configurationadapted for peritoneal dialysis medicament preparation, and optionallyperitoneal dialysis treatment also. The present configuration differsfrom that of FIG. 2C in that the present arrangement includes amechanism for connecting a circuit such as disposable fluid circuit 310of FIG. 2H which draws concentrate from a double connector 181A whichfits in slot 214A to receive concentrate through ports 283. The doubleconnector 181A also has a détente mechanism 216 to provide feedback tothe operator when a home (fully connected) position of the doubleconnector 181A is realized by inserting into the receiving slot 214A.The receiving slot 214A has a cutting and sealing actuator 212, drivenby controller 210, that cuts the tubes through the window of doubleconnector 181, 181A. The ports 283 may be supported on a replaceabledouble connector 273 as described in FIG. 2F so that these ports areprovided by a replaceable connector as part of a concentrate package 260as shown in FIG. 2F that includes concentrate containers 262 and 264 oris fitted to the receiving device 287 described above with reference toFIG. 2G. In alternative embodiments, the ports 283 may be part of theconnection platform 219. In that case, the tubes 290 and 292 may be partof the connection platform 219 and provided with separate connectors forconnecting the tubes 293 and 294 of the concentrate contains 262 and 264(FIG. 2F) or similarly to connect the receiving device 287.

As in the FIG. 2C embodiment, water from the purified water source 104is received in water line 245 via connection 244 and flows throughultrafilters 237. Pressure of the water suitable for peritoneal dialysissupply is monitored by a pressure sensor 218. A valve 234 selectivelycontrols the flow of water suitable for peritoneal dialysis to a doubleconnector 215. The purified water source terminates at a purified waterconnector 224 of the double connector 215. The double connector 215 alsohas a drain terminal connector 225, which splits at a junction 220 intoa path that flows to a pair of conductivity sensors 230, and then mergesat junction 238 to proceed to a drain 236 and a path that flows directlyto the drain 236. The selected path 247 is controlled by valves 232,240, and 242 which are controlled by a controller 210. The doubleconnector 181 previously described is received in a slot 214 whereconnections are made to the purified water connector 224 and drainterminal connector 225. A détente mechanism 216 provides tactile andaudible feedback to the operator when a home (fully connected) positionof the double connector 181 is realized by inserting into the receivingslot 214. A connector 239 serves as an adapter to permit connection tovarious types of drains. The connection platform 219 is also providedwith sensors including a moisture sensor 249 located to detect leakingfluid in the connection platform 219, a tilt sensor 226 to indicate theproper orientation of the connection platform 219, and a user interfaceto interact with the controller 210. The connection platform 219 may bereceived in a receiving slot 231 and may be formed as a unitaryreplaceable component. If sterility or leakage problems arise, theconnection platform 219 can be replaced easily.

Note that the configuration of FIG. 2I provides a simple and cleanconnection between the large concentrate containers and the disposable.However, there is no reason a direct connection could not be provided.That is, the long-term concentrate disposable may be provided with itsown connector to connect to a double connector 181A or similar connectoror pair of connectors. In another variation, shown in FIG. 2J, theconnection platform 219 provides a receiving connector for theconcentrate connector 181B, which may be attached to the receivingdevice 287 of the concentrate containers as shown in FIGS. 2F and 2G. Inthe connection platform 219 of FIG. 2J, a pair of lines 280 and 281connect the double connectors 181A and 181B so that concentrate can bedrawn by the peritoneal dialysis fluid proportioner/cycler 114 accordingto any of the various embodiments. Effectively, the connection platform219 in this case functions as a pass-through. The connection with double181B can be made on a low frequency basis according to the size of theconcentrate containers, and the connection with double connector 181Acan be made on a per-peritoneal dialysis treatment basis (or otherschedule) each time the mixing container 102 and associated fluidcircuit (e.g. 310) is replaced. FIG. 2K shows another mechanism forconnecting and controlling flow of concentrate to the peritonealdialysis fluid proportioner/cycler 114. Here connectors 289 connect to amanifold 297 with controllable valves 279 which open and close under thecontrol of a controller 213 to permit only a selected one of the watersuitable for peritoneal dialysis from a water line 296, the firstconcentrate from a first concentrate line 295A, and the secondconcentrate from a second concentrate line 295B. Each of these may bedrawn through common fluid line 298 through connector 224. Thus, thepumping actuator 125 of the peritoneal dialysis fluidproportioner/cycler 114 (FIGS. 1F and 1G) is able to draw each of thefluids. The controller of the peritoneal dialysis fluidproportioner/cycler 114 can be made to control the valves 279 bycommunicating with the controller 213 through a user interface 312. Thefunction of the controller 213 and user interface 312 (optional) may bethe same except as otherwise indicated across FIGS. 2I, 2J, and 2K. Notethat a single controller of the peritoneal dialysis fluidproportioner/cycler 103 (410, 109) or an independent controller commonto both (e.g. as indicated by 109 in FIGS. 1A to 1H) may be employed forcontrolling the described functions of the peritoneal dialysis fluidproportioner/cycler systems 90A through 90D.

FIGS. 2L and 2M show modifications of the connection platform of FIG. 2Kto provide for water and concentrate to be supplied through the commonfluid line 298. Referring to FIG. 2L, instead of a single manifold as inmanifold 297, a pair of junctions 222 is used, one to join the firstconcentrate line 295A and the second concentrate line 295B. Theconcentrates are pumped respectively, according to the selection ofvalves 250A and 250B which are controlled automatically by a controllerof the peritoneal dialysis fluid proportioner/cycler 103 or through aseparate controller 109 or through an interface by a dedicatedcontroller 213 of the connection platform 219 (or variations asillustrated in FIGS. 2L and 2M). If the fluid circuit 100B, 110D is usedwhich has a testable type of filter such as the filter 115 (e.g., FIGS.1B, 1C) having an air side and a fluid side separated by a membrane,then the fluid may advantageously be pumped by a pump 221 in a pushconfiguration with respect to the filter (arranged downstream of thepump 221 as is filter 115) rather than relying solely on a suction forceprovided by the pumping actuator through pumping tube segment 137. Aparticular concentrate is selected by valves 250A and 250B. A controlvalve 250C is also operated by the controller to control flow in thewater line 296. In any of the embodiments, water may be advantageouslypumped by a push pump 246 if water is supplied through a filtrationplant 223. For example, water may be filtered through reverse osmosis,deionization, activated carbon, and other types of filters in filterplant 223 to generate water suitable for peritoneal dialysis frompotable water. The pumps 221, and 246 may be controlled as indicatedabove with respect to the valves 250A and 250B to operate in tandem withthe pumping actuators of the peritoneal dialysis fluidproportioner/cycler (e.g., 103). Thus, the present variant of theconnection platform of FIG. 2K, functions to select one of multiplefluids among water and one or more concentrates thereby allowing allfluids to pass into the fluid circuit through a single inlet line (as inthe fluid circuit of FIG. 2E, for example). This allows a single filterto be used for sterilization. The embodiment of FIG. 2M, another variantof the connection platform 219 of FIG. 2K, may be employedadvantageously where a push pump such as push pump 246 (as in FIG. 2L)is not required to draw water, for example, if instead of using thecycler to prepare dialysis fluid, a premixed dialysis fluid is connectedto one of the inlets instead with suitable programming of the controllerto permit flow only from one of the premixed containers at a time. Here,control valves 279 select the fluid to be drawn each time and the pump221 draws the selected fluid, pushing it through the filter. Note thatin the embodiment of FIG. 2L, the pressure sensor 218 may be used forfeedback control of the push pump 246.

FIG. 3 shows a method of manufacturing a disposable circuit such as isdisclosed in FIG. 2A. First, the concentrate containers are filled atS10. The concentrate containers are then sealed with frangible elementsthat form a hermetic seal at S12. This isolates the contents of theconcentrate containers from the outside environment and causes them tobe protected from intrusion of contaminants. Then at S14, theconcentrate containers are connected to a remainder of the fluidcircuit, for example the disposable fluid circuit 200. The remainingportions of the fluid circuit are sealed by ensuring that end caps areplaced on any line terminations that are not interconnected within thecircuit. For example, caps are present on connector 185, sample ports168, and connectors 186 and 187. Finally, optionally at S16, the entirecircuit assembly with the concentrates, may be radiation sterilized orsterilized by other means.

FIG. 4A shows a peritoneal dialysis fluid proportioner/cycler accordingto embodiments of the disclosed subject matter. The present FIGS. 4Athrough 4K are generalizations of the various embodiments disclosedabove for purposes of explaining the operational use thereof forpreparing peritoneal dialysis fluid and for treating a patient using thestructures described above. Referring now to FIG. 4A, a peritonealdialysis fluid proportioner/cycler 400 may correspond to any of theforegoing embodiments described for generating dialysis fluid by mixingconcentrates and water. For example, note embodiments 90A-90D. Here, theperitoneal dialysis fluid proportioner/cycler 400 generates customperitoneal dialysis fluid according to a prescription stored in acontroller 410 (corresponding to controllers described above). Theprescription may be entered in the controller via a user interface 401,via a remote terminal and/or server 403, or by other means such as asmart card or bar code reader (not shown). The controller appliescontrol signals to a fluid conveyer and valve network 416 and a waterpurifier 420 and receives signals from distal and proximal pressuresensors 413 and 414, respectively, on a fill/drain line 450 which may bein accord with foregoing embodiments.

The fluid circuit with pump and valve network 416 is a fluid circuitelement with one or more sensors, actuators, and/or pumps which iseffective to convey fluid between selected lines 442, 444, 446, 448, 450and 418 responsively to control signals from the controller 410. Exampleembodiments are described herein, but many details are known from theprior art for making such a device so they are not elaborated here.

A multiple-container unit 441 includes a pre-filled, pre-sterilizedosmotic agent concentrate container for osmotic agent concentrate 402and another electrolyte concentrate container 404 for electrolyteconcentrate. The multiple-container unit 441 also contains the mixingcontainer 406 (which is empty) which is large enough to hold asufficient volume of dialysis fluid for the completion of at least onefill cycle of an automated peritoneal dialysis treatment. The containers402, 404, and 406 may be flexible bag-type containers that collapse whenfluid is drawn from them and therefore, do not require any means to ventair into them when drained.

Osmotic agent concentrate container 402, electrolyte concentratecontainer 404, and mixing container 406 are all connected by respectivelines 442, 448, 444, and 446 to the fluid circuit with pump and valvenetwork 416. The fill/drain line (or multiple lines) 450 and a drainline 418 for spent fluid (and other fluids) with a conductivity sensor428 may also be connected to the fluid circuit with pump and valvenetwork 416. The fluid circuit with pump and valve network 416 also hasa purified water line 431 for receiving water. The water purifier 420may be a purifier or any source of sterile and purified water includinga pre-sterilized container of water or multiple containers. In apreferred configuration, water purifier 420 may be configured asdescribed in WO2007/118235 (PCT/US2007/066251) and US20150005699, whichare hereby incorporated by reference in their entireties. For example,the water purifier 420 may include the flow circuit components of FIG.22A of WO2007/118235 including the water purification stages and conformgenerally to the mechanical packaging design shown in FIG. 24 ofWO2007/118235.

It should be evident that 416 is a generalization of the peritonealdialysis fluid proportioner/cycler 114 as well as elements of a fluidcircuit such as fluid circuit 112 and connection platform 219. It shouldalso be evident that 402 and 404 represent concentrate containersaccording to any of the disclosed embodiments including the concentratecontainers 101 and 102, 262 and 264, 105A and 105B. The mixing container406 corresponds to any of the mixing container embodiments (102)described above. Other elements will be evident from their descriptionwith the understanding that the figures represent generalizationsthereof for purposes of describing the function. It should also beunderstood that the number and type of concentrates may differ from thepresent figure which is disclosed as an example, only. It should also beevident that the examples of concentrates discussed herein are glucoseand electrolyte concentrates but they could be one or other multiples orother concentrates in other embodiments. Also, the osmotic agentconcentrate or glucose concentrate is presumed here to include anelectrolyte concentrate marker to permit the concentration of osmoticagent to be inferred from a measurement of conductivity of diluted agentwith a priori knowledge (stored in a memory used by the controller) ofthe ratio of osmotic agent concentrate to electrolyte concentrate in theosmotic agent concentrate. See US20150005699. In alternativeembodiments, the osmotic agent is not provided with an electrolytemarker and the peritoneal dialysis fluid proportioner/cycler 400 mayrely on volumetric proportioning for the transfer of osmotic agent. Notealso that the order of concentrate addition may be reversed, withelectrolyte being added first.

FIG. 4B shows a preliminary stage of fluid preparation prior toperitoneal dialysis treatment according to an embodiment of thedisclosed subject matter. The controller 410 reads a prescription andgenerates a command, responsive to a peritoneal dialysis treatmentpreparation initiation command, to flow osmotic agent concentrate fromosmotic agent concentrate container 402 to the mixing container 406. Thecommand is applied to the fluid circuit with pump and valve network 416to connect the osmotic agent concentrate line 442 to the batch fill line444 and also to convey the osmotic agent concentrate into the mixingcontainer 406. This may be done by one or more valve actuators and oneor more pumps that form the fluid circuit with pump and valve network416. The fluid circuit with pump and valve network 416 may be configuredto meter the quantity of osmotic agent concentrate precisely accordingto a predicted amount of dilution by electrolyte concentrate and waterto produce the desired prescription fluid. The metering may be performedby a positive displacement pump internal to the fluid circuit with pumpand valve network 416 or other means such as a measurement of the weightof the osmotic agent concentrate container 402 or the mixing containeror a volumetric flow measurement device.

In an alternative embodiment, part of the water (less than the totalused for dilution as discussed below with reference to FIG. 4C) is addedto the mixing container first, before the osmotic agent concentrate andelectrolyte concentrates (if needed) are pumped into the mixingcontainer.

Referring now to FIG. 4C, a dilution stage is performed using theperitoneal dialysis fluid proportioner/cycler 400. The controller 410,in response to the prescription, generates a command to flow purifiedwater from the water purifier 420 to the mixing container 406. Thecommand is applied to the fluid circuit with pump and valve network 416to connect the purified water line 431 to the mixing container 406 toadd a measured quantity of water to dilute the osmotic agent concentratein the mixing container 406. The controller 410 may control the fluidcircuit with pump and valve network 416 to ensure the correct amount ofwater is conveyed. Alternatively, the water purifier may incorporate aflow measurement device or metering pump or other suitable mechanism toconvey the correct amount of water. The controller 410 may be connectedto the water purifier 420 to effectuate the dilution result. The fluidcircuit with pump and valve network 416 may also be configured tocirculate diluted osmotic agent concentrate solution through lines 444and 446 either simultaneously with the dilution or after the dilutingwater has been transferred to the mixing container 406 according toalternative embodiments. The circulation mixes the contents of themixing container 406.

The relative amounts of water, osmotic agent concentrate, andelectrolyte concentrate may be realized based on the ratiometricproportioning properties of the pump. Since a single pump tube is usedto convey all the liquids into the mixing container, most sources ofoffset from predicted pumping rate (based on shaft rotations, forexample) to actual pumping rate affect all the fluids roughly equally.

Referring now to FIG. 4D, the diluted osmotic agent concentrate solutionin the mixing container 406 is tested to ensure that the correctconcentration of osmotic agent is achieved. In an embodiment, theosmotic agent concentrate 402 has an amount of electrolyte concentrateto generate a conductivity signal using the conductivity sensor 428 whenfluid from the mixing container 406 is conveyed by the fluid circuitwith pump and valve network 416 to the drain line 418 past theconductivity sensor. The amount of electrolyte concentrate pre-mixedwith the osmotic agent concentrate may be the lowest ratio ofelectrolyte concentrate to osmotic agent concentrate that apredetermined prescription may require. The fluid circuit with pump andvalve network 416 may perform the function using one or more valveactuators and one or more pumps that form the fluid circuit with pumpand valve network 416. The fluid circuit with pump and valve network 416may be configured to meter the quantity of water precisely or thefunction may be provided by the water purifier 420. The controller 410may add additional water or osmotic agent concentrate and test theconductivity again if the measured concentration of osmotic agent and/orelectrolytes, if applicable, is incorrect. In addition to using acombined osmotic agent and electrolyte concentrate in osmotic agentconcentrate container 402, in an alternative embodiment, the osmoticagent concentrate container 402 holds osmotic agent concentrate with noelectrolytes and osmotic agent concentration is optionally measureddirectly by other means such as specific gravity (hydrometer),refractive index (refractometer), polarization, infrared absorption orother spectrographic technique.

FIG. 4E shows an electrolyte concentrate addition stage of fluidpreparation prior to peritoneal dialysis treatment according to anembodiment of the disclosed subject matter. The controller 410 reads aprescription and generates a command to flow electrolyte concentratefrom container 404 to the mixing container 406. The command is appliedto the fluid circuit with pump and valve network 416 to connect theelectrolyte concentrate line 448 to the mixing container 406 fill line444 and also to convey the electrolyte concentrate into the mixingcontainer 406. This may be done by one or more valve actuators and oneor more pumps that form the fluid circuit with pump and valve network416. The fluid circuit with pump and valve network 416 may be configuredto meter the quantity of electrolyte concentrate precisely according toa predicted amount of dilution by osmotic agent concentrate and waterthat has been previously determined to be in the mixing container 406,to achieve the prescription. The metering may be performed by a positivedisplacement pump internal to the fluid circuit with pump and valvenetwork 416 or other means such as a measurement of the weight of theelectrolyte concentrate container 404 or the mixing container 406 or avolumetric flow measurement device.

Referring now to FIG. 4F, the electrolyte concentrate may be mixed usingthe batch fill and drain lines 446 and 444 in a closed loop. Ifnecessary, depending on how much dilution was performed during theosmotic agent concentrate dilution process, further dilution may beperformed as described above. The final formulation may be achieved bythe process illustrated in FIG. 4F. Then, as illustrated in FIG. 4G, thefinal electrolyte concentration of the mixture in mixing container 406may be determined with a conductivity sensor 428 by flowing a sampletherethrough.

Although gravimetric and tracer/conductance sensing were described asdevices for ensuring proper proportioning and dilution rates forachieving target prescriptions, it should be clear that any embodimentsof a peritoneal dialysis fluid proportioner/cycler disclosed herein mayemploy ratiometric proportioning as well, particularly where positivedisplacement pumping is employed. Ratiometric proportioning takesadvantage of the volumetric repeatability and predictability of certainpumps. For example, a particular pump can deliver a highly repeatablevolume of fluid for a given number of pumping cycles (pump rotations fora peristaltic pump or cycles for a diaphragm pump, for example). If alldialysis fluid components (water, osmotic agent concentrate, andelectrolyte concentrate, for example) are delivered to the mixingcontainer using the same pump, including, for example, the pumping tubesegment of a peristaltic pump, then the volume ratios of the componentswill, after adjustment for potential flow path and/or viscositydifferences as described below, be fully determined by the number ofpump cycles used to convey each component.

Ratiometric proportioning may supplement or substitute for measurementof the fluid conductance or density or other measurements. To convertthe number of pump cycles to actual displaced mass or volume, acalibration may be performed and/or flow path (including fluidproperties) compensation parameters may be employed. The flow pathcompensation parameters may be respective to each particular fluid flowpath and/or fluid type, or may be identical for all fluid paths andfluid types. To provide enhanced accuracy, one or more pump calibrationand/or flow path compensation parameters may be generated through acalibration procedure. Typically, flow path compensation factors will beestablished and stored in non-volatile memory. Typically, one or moreflow path calibration procedures will be performed when the peritonealdialysis fluid proportioner/cycler is used by a patient. The calibrationprocedure may be performed after each new fluid set is installed, orbefore each batch preparation cycle, or even multiple times during thepreparation of a single batch. A disposable fluid set may be installedevery day. The calibration procedure may be done using water. Thecalibration may sequentially pump fluid through one or more of thestages provided in Table 1.

TABLE 1 Example stages for sequentially pumping fluid during calibrationFrom To Water source Drain Mixing container Drain Osmotic agentconcentrate container Drain Electrolyte concentrate container DrainPatient access Drain Osmotic agent concentrate container Mixingcontainer Electrolyte concentrate container Mixing container Watersource Mixing container

In the calibration procedure, fluid is pumped between any or all of thepaths identified above. A separate calibration coefficient may begenerated for each of the paths. The calibration coefficient may bestored in a memory or non-volatile data store, for example, as aparameter representing the number of ml/per pump rotation (or diaphragmpump cycle), or as a proportionality ratio relative to a particularreference flow path. The actual fluid quantity transported during thecalibration step may be measured by any suitable device (flow sensor)including volume or mass measurement devices or direct flow ratemeasurement with integration, for example, using laser Dopplervelocimetry, thermal transit time, magnetohydrodynamics, propellerhydrometer, positive displacement flow measurement, differentialpressure through a resistance such as a venturi, nozzle, orifice plate,or other flow obstruction, variable area or rotameter, pitot or impacttube, vortex shedding frequency counting, ultrasonic, or other device. Aparticularly advantageous device for flow calibration is to measure thetransit time of a fluid property perturbation between spaced fluidproperty sensors as described below. Any of the disclosed embodimentsmay employ a flow sensor in which at least the portion of which thatcarries fluid is disposable so that the flow rate (or total displacedfluid quantity) can be input to a controller while allowing the use of adisposable fluid circuit. Examples include an ultrasonic soft tubeflowmeter made by Strain Measurement Devices SMD that non-invasivelymeasure flow in soft tubing by means of slotted transducers in which alength of tubing can be inserted during fluid circuit installation. Forcartridge embodiments, the PD cycler can employ a moving transducerstage that engages an exposed tube length of the cartridge after passiveinsertion of the cartridge.

The pumping system may also be sufficiently repeatable in a way thatallows precise ratios to be established without calibration, dependingon the predefined tolerances. If the manufacturing tolerances, includingmaterials, are sufficiently controlled, a desired level of control overratios may be achieved without in situ (point of care) calibration. Aparticularly sensitive component in terms of guaranteeing repeatabilityis the pumping tube segment of a peristaltic pump. In a firstembodiment, the peristaltic pump tube segment is made from a materialwhose mechanical and material tolerances are controlled withinpredefined limits. The lengths of the tubing circuit elements andmechanical parameters are also controlled within respective predefinedlimits. A calibration may then be done outside the peritoneal dialysistreatment context, e.g., in the laboratory, to calculate precise valuesto convert pump cycles to fluid quantity transferred for a single lot ofreplaceable fluid circuits. The calibration may be done for multiplelots. The calibration may also be done for each fluid circuit. Thecalibration may also be done by the peritoneal dialysis fluidproportioner/cycler for each fluid circuit. The calibration may also bedone for each batch of peritoneal dialysis fluid prepared by the fluidcircuit.

Referring to FIG. 4H, subsequent to the preparation of the contents ofthe mixing container 406 as described above, the fluid circuit with pumpand valve network 416 may be configured to drain the patient 411depending on the patient's prior status. Spent dialysis fluid may bewithdrawn by the fluid circuit with pump and valve network 416 andconveyed through the drain line 418. Then, the contents of the mixingcontainer 406 may be conveyed as illustrated in FIG. 4K to the patient.Here the controller 410 has configured the fluid circuit with pump andvalve network 416 to flow fluid to a patient 412.

Referring now to FIG. 5A, the double connector of 181, 181A, 181B isshown in detail as the connector embodiment 500. A single monolithicmember has a shape with at least one window, where two windows are shownone of which is indicated as window 512. The body 506 has a ridge 507that overhangs the frame 506 to permit the frame 506 overall to begrasped easily by a user, for pushing or pulling, to connect ports 515,516 to ports of a device (e.g., 219) to which lines 508 and 510 of afluid circuit 530 are to be connected. A releasable port cover 502 (seealso cap 180) seals ports 525 and 526 to prevent contamination thereof.The window 512 provides access to cut and seal elements that seal andcut the lines 508, 510 when the double connector 500 is to be replaced.Lines 508 and 510 pass through holes 514 in the frame 506. FIG. 5B showsthe double connector 500 after cutting and sealing, the sealed ends ofone end of cut tubes forming stubs indicated at 520 and 521 and theopposing ends at 522, 523. The ends 522, 523 remain attached to a fluidcircuit 530 which is to be replaced. The stubs 520, 521 remain attachedto a resulting stub connector 519 which can remain attached to aconnected device, after use, so as to act as a cover and seal againstenvironmental contamination of a connected device, such as connectionplatform 219 connectors 224 and 225. Here, the protected ports of theconnected device are indicated at 525 and 526. Although two channels areshown, it should be evident that the configuration may be modified toprovide connections for any number of channels including one or morethan two.

Referring to FIGS. 5C and 5D, the use of a connector 500 (which may be adouble connector) including a cut and seal operation in which a portion540 of a connector (e.g., double connector 181) is left in place to actas a sterile barrier begins with the removal of a sterile barrier-typecap from the end of the connector S32. For example, the sterile barriermay take the form of the double releasable port cover 502. Next, as S33,the sterile barrier formed by a previous connector which was cut andsealed (see FIGS. 6A-7D and elsewhere in the present disclosure) isremoved, and a new replacement connector of the same form as theconnector 500 is attached S34. Then the circuit connected by means ofthe new connector is used until it is expired S35. A cut and sealoperation is initiated at S36, resulting in the separation of the fluidcircuit (cut and sealed forming the stubs 520, 521 and ends 522, 523)and a new portion 640 of the new connector to be left in place to act asa sterile barrier. The cut and seal operation may include cooling thecut ends of the tube to speed the operation so that a delay forsufficient passive cooling is not required. The latter may also permitthe cutting heads to act as a mechanism for gripping the stubs 520 and521 to prevent them being removed before cooling. See, for example, theembodiment of FIGS. 6E and 6F which have a broad flat interface forgripping the ends of the cut tube 666.

FIG. 5E shows features for a variation of a double connector 501 thatprotects against contamination. A male connector portion 541 mates witha female connector portion 543. Ports 526 (male) pass through openings547 of female ports 548. A pin 545 is provided on the male connectorportion 541 that is received within a recess 546. The female ports 548open in a wall 524 as does an access 549 of the recess 546. Lines 544connect to the male connector portion 541. The remainder of the doubleconnector 501 is as described with reference to connector 500 shown inFIGS. 5C and 5D. The pin 545 may be sized to prevent the ports 526 fromcontacting a flat surface inadvertently and thereby prevent contactcontamination. The pin 545 may also be shaped asymmetrically to preventincorrect orientation of the connectors. In variations, the doubleconnector 501 may be modified such that it has a greater or lessernumber of tubes 508, 510, and connectors 547. Also, the number of pins545 and recesses 546 may differ from what is shown. For example, twopins and recesses may be provided at the edges 527 with or without theillustrated pin and recess. Note that in variations of the embodiments,the male and female connectors may be swapped or mixed on a given sideof the male connector portion 541 and the female connector portion 543.One or more pins 545 may be provided on either side or mixed, as mayopenings 547.

FIG. 6A shows mechanical aspects and a control and sensor system for thecut-and-seal devices with actuation, temperature, and force controlfeatures, according to embodiments of the disclosed subject matter.FIGS. 6B through 6D show a sealing and cutting operation provided by theembodiment of FIG. 6A. A pair of jaws 11 and 18 close on opposite sidesof a tube 50 to cut and seal the tube 50 such that the tube 50 isdivided into two parts with ends 54A and 54B sealed. The jaw 11 receivesheating or cooling through a conveyance 20A or multiple conveyances 20Bwhich may be electrical conductors for resistive heating element 14 or acombination of heating and cooling heat transfer fluids such as moltensalt and refrigerant. The source of heat/cool or current supply isprovided by a source 6. Either jaw 11 or 18 may be heated to achieve thedescribed effect in alternative embodiments. A drive 2 under control ofa controller 4 moves at least one of the jaws 11 and 18 toward the otheror together. Temperature sensors 16 and 12 may be provided to regulatethe temperature and provide feedback control for a cutting and sealingoperation. The controller 4 may receive the temperature signals andcontrol the drive 2. A force sensor 40 may indicate to the controllerthe magnitude of force applied through the tube 50 for feedback controlof a cutting operation or for error detection (out of bounds force, forexample). The cutting heads can have various shapes as shown in FIGS.7A-7D. FIG. 7A illustrates opposing jaw shapes with jaw 604 having aflattened tip 606 and jaw 602 having a flat surface. FIG. 7B illustratesopposing jaw shapes with jaw 614 having a sharp tip 616 and jaw 602having a flat surface. FIG. 7C illustrates opposing jaw shapes with jaw624 having a rounded tip 626 and jaw 622 having a flat surface. In FIG.7D, a sharp ridge 636 is provided on jaw 634 and a recess 637 on jaw635. An alternative jaw 632 that may be used with the jaw 634 has a flatsurface 638.

FIGS. 6E and 6F show a cut and seal arrangement in which the cutting andsealing portions move partially independently. A cutting knife 662 cutsa tube 666 when a jaw 658 pushes up against it. The jaw 658 or the jaw654 (or both) may be heated to melt the tube 666 such that tube is cutand sealed in a single operation. A spring 664 ensures that a predefinedamount of force is maintained for heating the tube 666 during theclosing of the jaws. FIG. 6G shows a configuration in which the jaws arerounded elements 670 and 672 which may cut and seal the tube 666 whereeither or both jaws may be heated. Cooling in the above embodiments maybe provided to cool the jaws and the tubing cut ends for safety or speedof completion. The arrangements of FIGS. 6A through 6F are details thatmay apply to the cutting and sealing actuator 212.

Referring to FIGS. 8A and 8B, a multiple chamber portion 200D (e.g.,FIG. 2A) of disposable fluid circuit 200 is shown in greater detail.Features of the present embodiment may be applied to other fluid circuitportions as well, including the single mixing container 300C (FIG. 2E).Concentrate containers 953 and 954 and mixing container 952 are formedfrom a single pair of sheets by welding seals 962, shown as a pair oflines all around the depicted structure. Concentrate fill tubes 964,concentrate outlet tubes 956 and 957, mixing container inlet 948 andoutlet line 9541, as well as a mixing container sample tube 958 are allwelded as the seals 962 are closed by solvent bonding, thermal welding,polymer fill-bonding, ultrasonic welding, or other means. The entirestructure may then be folded as shown in FIG. 8B to form a compactstructure before or after a predefined quantity of concentrate isconveyed through the concentrate fill tubes 964 and the latter sealed.

A nozzle 950 may terminate the mixing container inlet 948 tube whichextends into the chamber. This causes the extended part of the tube towhip around to inject incoming fluid around the mixing container 952 toagitate the contents and promote effective mixing of the contents. Themixing container sample tube 958 may be terminated by a septum to permitthe insertion of a hypodermic needle. The length of the extended partmay be at least 3 diameters into the container. The length may be five,7.5, 10, or 15 diameters. The length may be between 3 diameters and 25diameters. The length may be at least 5 diameters. Here, the termdiameter refers to the tube outer diameter. Note that anotheralternative is for the inlet line to have a nozzle but no extended part,that is, the nozzle may be located at the wall of the mixing containerand be aimed toward the center of the mixing container.

FIGS. 8C through 8F show various features to promote mixing of fluids ina mixing container according to embodiments of the disclosed subjectmatter. A mixing container 952 uses a single mixing container inlet andoutlet line 949 that functions as a mixing container 952 inlet andoutlet line 949. FIG. 8C shows a fluid outgoing from the mixingcontainer 952 and FIG. 8D shows fluid incoming into the mixing container952. A two-way header 924 has a check valve 918 that allows outgoingfluid to be drawn through an opening 920 into the mixing container 952inlet and outlet line 949 but blocks flow out of the opening 920. Whenfluid is pumped into the mixing container 952, the check valve 918closes and all of the flow is forced through a nozzle 924 so that itemerges at high velocity from a nozzle opening 922 as illustrated inFIG. 8D. As result, mixing is promoted and a substantial convective flowor jet is generated to transport the incoming flow to locations remotefrom the opening 920, thereby promoting mixing. A similar effect isobtained in the embodiment of FIG. 8E in which incoming flow is releasedfrom a tube 937 inside the mixing container 952 from an opening 930remote from the opening 920. In this embodiment, also, a check valve 918causes the incoming and outgoing flows to take different paths. Notethat a check valve, although not shown, may be incorporated in the flowpath of the tube 937 or the nozzle 924 to block flow through opening 922or 930 when fluid is pumped out of the mixing container 952 to enhancethe separation effect between the ingoing and outgoing flows. FIG. 8Fshows an embodiment in which the container inlet and outlet line 949attaches to a header tube 934 that is similar in structure to aperitoneal catheter in that it has openings distributed along a portionof its length such that ingoing flows are distributed. Such a headertube 934 may be used as a single container inlet and outlet line as for949 or, in combination with a dedicated outlet line 9542, as an inletline. In the foregoing embodiments, instead of a check valve, a flexiblemember such as a reed or flap valve as indicated in FIG. 8G, whichcreates greater resistance for flow in one direction than another, maybe employed. So flow does not necessarily need to be halted altogetherin a selected direction to achieve substantially the above effect. InFIG. 8G, a single part that may be formed, for example, by 3D printing,assembled from parts, or molded directly has a flap 921 that bends inresponse to both suction and pressure resulting from pumping fluid fromand to the mixing container 952, causing flow out of the mixingcontainer to be drawn through the inlet covered by the flap 921 and tobe projected by the nozzle 924 when fluid is pumped into the mixingcontainer as described with reference to FIGS. 8C and 8D. Here the flap921 need not fully close or open but may, in embodiments, merely createa differential resistance to ingoing and outgoing flows such that fluidpumped into the mixing container is projected away from the locationwhere it is drawn in, thereby facilitating the mixing process.

FIG. 4L illustrates schematically a variation of the peritoneal dialysisfluid proportioner/cycler 400 of FIG. 4A with the addition of anaccumulator 447 connected by an accumulator line 449 to allow a pumpsuch as a peristaltic pump according to any of the disclosedembodiments, to provide mixing with a single mixing container line 445connecting the mixing container 406. The controller 410 pumps fluid fromthe mixing container 406 to the accumulator 447 back and forth multipletimes to mix the contents of the mixing container 406. This is incontrast to the disclosed embodiments in which two lines connect themixing container 406 to the fluid circuit with pump and valve network416. As indicated, use of a pump that has the ability to accumulatefluid, such as a diaphragm pump, may allow fluid to be pumped into andout of the mixing container 406 without a separate accumulator 447, bypumping fluid into the mixing container 406 from the diaphragm pumpinternal volume. Reference numeral 451 points to the arrows indicatingspaced ingoing and outgoing flows to/from the mixing container that maybe provided by the foregoing embodiments of devices for separating (atleast partially) the ingoing and outgoing flows.

Referring to FIG. 9A, a manifold 900, which functions as manifold 174(e.g., FIG. 2A), has two chambers 982 and 981 defined by the shape of arigid housing 989 that is sealed by a welded or bonded film 986. Rigidhousing 989 may be formed by casting and an internal volume sealed bythe bonded film. The film has regions 987 overlying the housing forpressure detection. Pressure transducers (not shown) contact the regions987 and detect a force applied by pressure within the chambers 982 and981 at either end of a pumping tube segment 985 which connects the twochambers 982 and 981. Respective ones of ports 983, for the variousfluids described herein according to the different embodiments, conveyfluid to respective ones of the chambers 982 and 981. Tubes may befriction fitted or bonded to the ports 983. The ports 988 have air-linesattached to them and these are respectively fluidly coupled to air ports990 which sealingly engage pressure transducers (See 146 and 147 of FIG.2B). In other embodiments, the rigid housing 989 is replaced with afully enclosed housing (not shown) with pod type pressure sensorsembedded in them and there is no film required for sealing the structureclosed.

Referring to FIG. 9B, a dialysis fluid line 172 has a pre-connectedfill-drain line 160 and an air-line 129 as well as a pressure-sensingpod 162 which has an internal diaphragm which is displaced responsivelyto pressure changes in the pre-connected fill-drain line 160 near thepatient connector 995. Movement of the internal diaphragm compresses orexpands an air volume in the air-line 129 which is conveyed to aconnector 181. The patient connector 995 connects to a peritonealcatheter. The proximal end 997 of the pre-connected fill-drain line 160is attached or bonded to a respective one of the ports 983.

Referring now to FIGS. 10A and 10B, a cartridge portion 910 of the fluidcircuits according to the various embodiments provides the manifold andthe pumping and pressure sensing portions previously described. Thecartridge support 169 may be made from a single panel 912 that is foldedat a pair of creases indicated at 914. The panel 912 portions containrecesses for all the tubes held between them precisely controlling theirpositions. A compartment is defined by the shapes of the panels to holdthe rigid housing 989. FIG. 2A shows an alternative embodiment in whichthe manifold 174 is connected by a battery of tubes indicatedcollectively at 200C so the double panel structure is not directlyattached to the manifold 174. FIG. 11 shows the single vacuum formedpanel 912 before it is closed about the pair of creases 914. FIG. 11otherwise shows a complete fluid circuit 909 including how the featuresof 8A through 10B are assembled in a completed fluid circuit 909.

In any and all of the foregoing disposable fluid circuits, thecomponents may be integrally-attached, meaning the components may bepermanently bonded or otherwise locked together as delivered for useexcept for removable caps on inlets and outlets. In embodiments, only asingle cap may be required to connect one or more concentrate inlets anda single cap may be required to connect a peritoneal dialysis catheterto the integrally-attached fill/drain line. This helps to ensure that afluid circuit as-delivered will have less of a chance of beingcontaminated as a result of having only a small number of connections.

Generally, in systems that process or treat fluids and return processedor treated fluids to a patient, it is necessary to eliminate air fromthe fluid circuit prior to and/or during use to avoid introduction ofair into the individual undergoing treatment. This may be accomplishedby “priming” the fluid circuit which refers to circulating a fluid inthe fluid circuit so that the fluid circuit is filled prior to treatinga patient.

In the disclosed embodiments, preparing a complete batch for a PDtreatment cycle, which is hereinafter referred to as the “main” batch,may take a certain minimum amount of time depending on the number ofcomponents that need to be mixed, the amount of fluid required fortreatment of a patient, the need for proportioning error recovery, etc.For example, preparing a full batch of peritoneal dialysis fluid maytake a significant fraction of an hour. Generally, the full batch willalso be used for priming the fluid circuit when the new fluid circuit isloaded. Since the fluid circuit generally should be primed before beingconnected to the patient, the patient would have to start preparation ofa full batch and then wait until the full batch is prepared beforeconnecting and then either getting in bed or attending to some otheractivity such as relaxing. Thus, a patient desiring to connect to thecycler may be required to perform initial activities includingattachment of a new fluid circuit to the cycler and then wait for a fulltreatment batch to be fully prepared before connecting to the fluidcircuit. In a situation where the patient is tired and wishes to connectquickly in order to go to sleep or perform some other activity, thisdelay may be inconvenient. In particular, this delay may cause lostsleep and impact patient health.

In embodiments, a priming batch which is considerably smaller in volumethan the treatment batch is first prepared and used for priming thefluid circuit so that the patient does not have to wait for the fullbatch to be prepared before the patient connects to the fluid circuit.The smaller volume of the priming batch may be just sufficient to primethe fluid circuit. In alternative embodiments, the smaller batch has adifferent composition which may be faster to generate than thecomposition of the batch used for treatment. For example, in embodimentsin which multiple concentrate components are diluted by combining withwater to form a treatment batch, a subset of the multiple concentratesand water is used to form the priming batch. In embodiments, the subsetmay include only water. In further embodiments, the priming fluid may bea blood-normal fluid, or formed from a concentrate that is differentfrom the composition of the treatment fluid. For example, the singlecomponent may be a saline fluid or concentrate. Since the priming fluidis used solely for priming, there is minimal advantage to including anosmotic agent concentrate as does regular PD fluid.

The disposable fluid circuit that includes a small priming batch orconcentrate container may be pre-attached and sealed to the disposable.After priming, the priming fluid may be flushed from the fluid circuitto the drain along with the spent dialysis fluid during initialtreatment stage so that the composition of the dialysis fluid suppliedto the patient is not altered by the differing composition of thepriming fluid. Thus, the method of priming may include, followingpriming the fluid circuit, including the fill-drain line, pumping spentdialysis fluid from the patient immediately to the drain and flushingany portions of the fluid circuit containing residual priming fluid withthe first treatment batch of fluid prior to filling the patient with afresh batch. In this way, the quantities and proportions of fluid forthe treatment do not have to account for any impact of the compositionof the priming fluid. This can be the case irrespective of the type offluid used, be it saline, pure electrolyte concentrate, purified water,or some other fluid.

In further embodiments, the disposable fluid circuit is provided with acontainer of priming fluid. The latter may be filled with a single ormulti-component concentrate which is further diluted in preparation forpriming or it may be provided fully diluted and ready for use. Thepriming fluid container may be pre-attached as described with referenceto the concentrates described in the disclosed embodiments. Note that asingle component concentrate container may be provided for priming-onlybecause the weight and volume-saving benefits of the embodiment may beless important for the small volume of priming fluid than for treatment.

Accordingly, embodiments allow for quick priming and patient connection.In some embodiments, the quick priming may be provided as auser-selectable option, and if the user does not select the option, thesystem simply starts by preparing the treatment batch and using it forpriming the fluid circuit.

In embodiments, the priming batch is mixed in the same disposable unitas used for the treatment batch. For example, with reference to FIG. 1A,the dialysis fluid preparation/cycler unit 103 may generate the primingbatch by metering concentrate from concentrate containers 101 and addingthem to, and diluting them with purified water in, the mixing container102. However, in alternative embodiments, the priming batch may bestored separately from the treatment batch. In embodiments, the primingbatch is formed from a subcombination of multiple components used forpreparing a treatment batch. For example, the priming fluid may beformed from only the electrolyte concentrate component and water withoutmixing the osmotic agent concentrate. In this way time may be saved byonly diluting and mixing a single component. In such embodiments, thecomposition of the single component used to make the priming batch maybe selected such that when mixed with the second component it forms adialysis fluid that is suitable for treatment and when mixed with wateralone, it forms a desired blood-normal fluid.

FIG. 12 shows a method of priming a fluid circuit according toembodiments of the disclosed subject matter. At optional step 1202, acontroller determines that the patient has selected an option for quickpriming, for example, by activating a soft or hard key on a userinterface in communication with the controller. Alternatively, quickpriming may be performed by default and without receiving any explicitindication from the patient. If the patient chooses not to do quickpriming, the method of FIG. 12 is not executed. In embodiments, thecontroller may request an indication of whether the patient is full ordry, meaning whether the patient's peritoneum is already full andtherefore to be drained initially, or empty (dry) in which case theperitoneum is not to be emptied. If empty, the quick prime operation isskipped and a full batch of treatment fluid is made. The purpose ofquick prime is to allow the drain cycle to be initiated quickly, so thepatient doesn't have to wait for the cycler to prepare a full batch oftreatment fluid. For example, this may be done at a time the patient isgoing to bed.

At 1204, the controller determines a composition for the priming fluid.For example, the composition may be based on a prescription or otherdata stored on a memory device connected with the controller. Inembodiments, the composition may be configured by a physician or otherhealthcare professional via the user interface or over a networkcommunication with a server or a central control system at a medicalfacility. In embodiments, the composition may be the same as used forthe treatment of the patient, another composition as discussedelsewhere, or it may be water or saline solution.

At 1206, the controller determines a required volume of priming fluid.The determination may be a predefined volume stored in a non-volatiledata store connected with the controller. In embodiments, the requiredvolume may be configured by a physician or other healthcare professionalvia the user interface or over a network communication with a server ora central control system at a medical facility. In embodiments, therequired volume may be based on physical properties of the fluid circuitsuch as the length and diameter of fluid lines.

At 1208, the controller operates a dialysis fluid preparation/cyclerunit and corresponding connections/valves/pumps to prepare the requiredvolume of the priming fluid according to the composition. For example,with reference to FIG. 1A, the dialysis fluid preparation/cycler unit103 may generate the priming batch by metering concentrate fromconcentrate containers 101 and adding these to, and diluting them withpurified water, in the mixing container 102 according to methodsdescribed elsewhere in the present disclosure or other methods such asdescribed in US 2015-0005699A1, a copy of which is attached hereto as anappendix.

At 1210, the controller primes the fluid circuit with the priming fluid.The priming may be performed by pumping fluid as in the preparationphases described above to generate a batch of smaller size, and thenpumping the resulting mixed batch through the fill/drain line (e.g.,450, FIG. 4A) until some reaches a point near the end of the fill/drainline. In embodiments in which water is used alone, water may be pumpedinto the mixing container and then into the fill/drain line, therebyfilling the flow switching mechanism. The described flow diverters mayalso permit the water to flow from the mixing container to the drainthereafter, in preparation for making the first batch of a sequence fortreatment.

At 1212, the controller indicates to the patient that the fluid circuitis primed and ready to be connected. The indication may be performed bygenerating a visual and/or audible alarm and corresponding text on theuser interface. At this time, the patient may connect to the fluidcircuit. Alternatively, the patient may indicate when fluid has reachedthe end of the fill/drain line by inputting a command through the userinterface, the result of which would be to ready the system to begintreatment after the patient indicates s/he has made a connection to theperitoneal access.

At 1214, the controller may confirm that the patient has connected thepatient access to the fluid circuit, for example by receiving anindication/confirmation via the user interface and/or by receivingsensor inputs (proximity sensors, switches, etc.) that indicate aphysical connection of the fluid circuit to a catheter. The distalpressure sensor may be used by the system to confirm connection byhaving the controller detect and respond to pressure signals frompatient respiration or pulse. At this time, the patient may place thesystem in a treatment mode at 1216 and allow automated treatment toproceed without attending to the system any longer. For example, thepatient may go to sleep to receive a nocturnal treatment.

Referring to FIG. 13A, a fluid circuit has an attached priming fluidcontainer 706. The fluid circuit includes a flow switching circuit 708with a manifold and a pre-attached fill/drain line 710. Concentratecontainers 703 and 704 are diluted as described to form a treatmentbatch which fills a mixing container 702. A priming concentrate may beprovided in container 706 or, alternatively, a container of fullydiluted priming fluid 707 is attached. The latter may be used asdescribed above. FIG. 13B shows a fluid circuit that may be used toprovide a priming batch by mixing a special composition from largercontainers 724 of concentrate or fully diluted container 725alternatively. The configuration may employ a multiple connector 726 asdescribed elsewhere for connection to the long-term concentratecontainers 720 and 722 for treatment batch preparation. In yet otherembodiments, the fluid circuit may have a pre-attached priming fluidcontainer (concentrate or diluted) and the multi-use container 724 or725 may be omitted.

In alternative embodiments, quick priming may be done with priming fluidthat remains in the mixing container after a normal priming process isused to prime the fluid circuit. The normal fluid circuit primingprocess begins with pumping water into and through the fluid circuitincluding circulating fluid into and out of the mixing container, atleast partly in order to break-in the pumping tube segment, ultimatelyleaving a volume of, for example, four hundred ml. in the mixingcontainer. The sterilizing filter protecting the water inlet accordingto any of the foregoing embodiments may then be tested to confirm itsintegrity after the priming operation. If the filter integrity isconfirmed by the testing, this indicates the fluid in the mixingcontainer which has passed through the sterilizing filter, the mixingcontainer and fluid circuit being sterile as initially provided, mustalso be sterile, at least with a high certainty. That is, the only meansby which contaminants can enter the mixing container, which ispre-sterilized, is through at least one filter (see foregoingembodiments), which essentially guarantees the contents are sterile. Thequick prime operation may be performed using a portion of the contentsof the mixing container. Other limitations of the quick priming asdiscussed above may be as indicated except for the use of concentrate.

Note that the quick prime procedure is contraindicated if the patientbegins a treatment without a full peritoneal cavity. The term “full” inthis context does not specify a particular volume, except that it shouldbe sufficient for the treatment following the quick prime to begin withan initial drain cycle.

In any of the claimed embodiments identifying an element, it isunderstood that the identification of an element does not preclude theclaims covering embodiments having multiple ones of the elements. Forexample, in any of the claimed embodiments identifying a concentrateline or concentrate container, it is understood that the identificationof a single concentrate line or container does not preclude the claimcovering multiple concentrate lines or concentrate containers. Furtherembodiments are contemplated in which multiple ones of the claimedelements may be provided to form additional embodiments, for example,the concentrate lines or containers. The same applies to method claimswhere additional steps may be provided to form new embodiments, wherethe additional steps repeat an operation performed by a recited step andact upon another material or article in equivalent fashion, for example,an additional concentrate.

Referring now to FIGS. 15A-15C, method and system embodiments forproportioning concentrates and water are described. FIG. 15A shows aflow chart of the proportioning procedure next to a schematic diagram ofthe mixing container contents 320. The diagram at each stage ofprocessing has rows 321 through 336, each of which shows a figurativerepresentation of components of electrolyte, osmotic agent, and thewater contained by the container after addition of a fluid. In thisexample, the osmotic agent concentrate contains both osmotic agent withwater so its addition to the mixing container adds osmotic agent,electrolyte, and the water contained in the osmotic agent concentrate.See row 322 column 338. Row 321 shows the mixing container containswater alone after addition of water. Row 322 shows the components ofelectrolyte and osmotic agent plus the water contained by the osmoticagent concentrate all of which are combined to form the osmotic agentconcentrate plus electrolyte marker added at S108.

The rows 322 through 336 are aligned with the process stages S106through S122 and each row shows a composition that exists, or isachieved by, the corresponding process stage. Columns 338, 339, and 340show the concentrates and water components. The concentrates are furtherbroken down in the columns to indicate the constituents thereof. Again,the osmotic agent concentrate 338 has constituents water, osmotic agent,and electrolyte used as a marker. These constituents are indicated by“E,” “O,” and “H2O.” The electrolyte concentrate 339 has constituentselectrolyte and water indicated by “E” and “H2O.”

In an initial operation S100 the fluid circuit, including the manifold,if one is present (the method is not exclusive to the mechanicalfeatures of the foregoing embodiments as will be evident from thepresentation), is primed with water and the water is circulated throughthe mixing container to break-in the pump tube segment. The sterilizingfilter, through which water is drawn, may be tested at this point toensure its integrity. At S102, if a quick prime is to be performed, thebatch contents may be used for this purpose. Either way, the remainingbatch contents are emptied to the drain S104. The controller storesfinal target quantities of water, osmotic agent concentrate, andelectrolyte concentrate ultimately to be transferred to the mixingcontainer, mixed, and tested. Initially the mixing container is empty.At S106, an initial quantity of water is transferred to the mixingcontainer. Prior to S106, the mixing container is essentially empty,although there may be a small residual trace from the priming operation.The resulting batch contents are indicated in alignment with the S106process in row 321. The quantity of water may be optimized to minimizemixing time. In embodiments, the water quantity may be 50% of the targetwater requirement. At S108 osmotic agent concentrate is transferred tothe mixing container as required by the target composition. Thetransferred osmotic agent concentrate illustrated at 322 indicates thethat entire target quantity of concentrate is transferred. Alsoillustrated at 322 is that a quantity of water and a quantity ofelectrolyte concentrate are also transferred as part of the osmoticagent concentrate 338.

Note that the target quantities of the electrolyte, the osmotic agent,and water can be stored as the quantities of electrolyte concentrate andosmotic agent concentrate or the quantities of the undissolved species.The quantities can be converted between each and can be stored as volumeor mass or other suitable measure.

In the present embodiment, the volume of osmotic agent concentrateincludes electrolyte as a marker, which contributes to the amount ofelectrolyte of the target stored by the controller. If a final dialysisfluid requires no more than the quantity of electrolyte appearing in theosmotic agent concentrate to function as a marker, then the quantity ofelectrolyte concentrate transferred in this initial step is sufficientto form the final dialysis fluid. Next, the mixing container contentsare mixed by pumping at S110. At S112, the batch content conductivity istested to determine if the concentration is as expected. The controllermay store a number indicating a number N of conductivity retests thatcan be performed in the event the conductivity test result is outside ofan expected range. To retest, the controller mixes the contents of themixing container again. In embodiments, this latter mixing may be for ashorter predefined interval than a predefined interval of operationS110. The testing and mixing may be iterated the N number (N being apredefined number) of times and if the final test fails, the preparationis halted and a recovery operation invoked, for example, halting pumpingand outputting a display to restart preparation with a new disposablefluid circuit. Through S108 to S112, the contents of the mixingcontainer remain the same as indicated at 324 and 326.

If the final dialysate calls for a higher ratio of electrolyteconcentrate to osmotic agent concentrate than is in the osmotic agentconcentrate, then at S114, a corresponding quantity of electrolyteconcentrate is added to the mixing container. Otherwise operations S114,S116, and S118 are skipped. Proceeding with S114, the mixing containercontents are mixed at S116 and a conductivity check is performed at S118with M iterations where M may be any number including equal to N. Thebalance of the required water for achieving the target is added at S120.At that point the final composition indicated at 334 and 336 isobtained. Then, as above, the mixing container contents are mixed atS122 and a conductivity check is performed at S124 with L iterationswhere L may be any number including equal to N or M. In a finaloperation S126 the one or more filters used to protect against touchcontamination (depending on the configuration of the fluid circuit) istested to confirm its integrity during the fluid proportioning.

The reason only a fraction of the water is added initially at S106, evenif the ratio of electrolyte to osmotic agent in the osmotic agentconcentrate is correct for the target dialysis fluid, is that mixinginitially with part of the water and then again with the remainder ofthe water may reduce the total mixing time compared to adding all of thewater at once at S106.

In the foregoing methods, there were described three steps of mixing andtesting. Within any of these operations, a titration process may be usedto adjust the quantity of water or concentrate added to the mixingcontainer or for adjusting the accounting of the total volume of waterto be added in a final dilution operation. At S112, for example, inembodiments, the amount of osmotic agent concentrate may be increased ifthe conductivity measurement indicates the quantity falls below aminimum mass of osmotic agent (the solute) for the target dialysisfluid. Since ratiometric proportioning is relied upon, such a correctionwould assume that the amount of water transferred is validly quantifiedand the osmotic agent concentrate quantity is inaccurate. If testingindicates that the quantity of osmotic agent concentrate is consistentlyless accurately or precisely metered by the pumping than the water, thenthis correction would be valid for such systems. In further embodiments,the controller may be programmed so as to make an adjustment in theconcentrate only after a predefined number of mixing/testing reattempts.This will ensure against any concentration bias resulting fromincomplete mixing. When a dialysis fluid is being made, whose ratio ofelectrolyte to osmotic agent is identical to that in the osmotic agentconcentrate containing electrolyte concentrate as a marker, the testingof the batch contents at S112 is sufficient to indicate theconcentrations of both the osmotic agent concentrate and electrolyteconcentrate because the ratio of electrolyte concentrate to osmoticagent concentrate is fixed in the osmotic agent concentrate. Manydialysis fluids are characterized by standard ratios of osmotic agentconcentrate to electrolyte concentrate. If the highest osmoticagent/electrolyte ratio of such a fixed set is equal to the proportionof electrolyte concentrate used as a marker in the osmotic agentconcentrate, then this ability to confirm the final dialysis fluidquality by a conductivity test will be available. A controller may beprogrammed to control the proportioning process such that a final batchis cleared only after confirmation of the final conductivity. Forstandard dialysis fluids having lower ratios of osmotic agent toelectrolyte, the system may rely on ratiometric proportioning.

FIG. 15D shows a flow chart of another proportioning procedure next to acorresponding schematic diagram of the mixing container contents 320. Asin FIG. 15A, the diagram at each stage of processing has rows 351through 366, each showing a figurative representation of components ofelectrolyte concentrate, osmotic agent concentrate with no electrolytemarker, and water. As discussed with reference to FIG. 15A, theconcentrates contribute some water in addition to the respectiveelectrolyte and osmotic agent components they contribute. Also, the rows351 through 366 are aligned with the process stages S206 through S222,with each row showing a composition that exists at the correspondingstage. Columns 368, 369, and 370 show the concentrates and watercomponents. The concentrates are further broken down in the columns toindicate the constituents thereof. The osmotic agent concentrate 368 hasas constituents osmotic agent and water only. No marker is used. Theelectrolyte concentrate 339 has as constituents electrolyte and water.The constituents are indicated by “E,” “O,” and “H2O” as in FIG. 15A.

In an initial operation S200, the fluid circuit including the manifold,if present, is primed with water and the water is circulated through themixing container to break-in the pump tube segment. The sterilizingfilter through which water is drawn may be tested at this point toensure sterility. At S202, if a quick prime is to be performed, thebatch contents may be used for this purpose. Either way, remaining batchcontents are emptied to the drain S204. The controller stores finaltarget quantities of water, osmotic agent concentrate and electrolyteconcentrate ultimately to be transferred to the mixing container, mixed,and tested. Initially the mixing container is empty. At S206, an initialquantity of water is transferred to the mixing container. Prior to S206,the mixing container is essentially empty although there may be a smallresidual trace from the priming operation. The resulting batch contentsare indicated in alignment with the S206 process in row 351. Thequantity of water may be optimized to minimize mixing time. Inembodiments, the water quantity may be 50% of the target waterrequirement. At S208 electrolyte concentrate is transferred to themixing container as required by the target composition. This may be thefull quantity of electrolyte concentrate required in the targetcomposition. The transferred electrolyte concentrate illustrated at 352indicates the quantity of electrolyte solute that is transferred. Alsoillustrated at 352 is that a quantity of water is also transferred aspart of the electrolyte concentrate 369.

Next, the mixing container contents are mixed by pumping at S210. AtS212, the batch content conductivity is tested to determine if theconcentration is as expected. The controller may store a numberindicating a number N of conductivity retests that can be performed inthe event the conductivity test result is outside of an expected range.To retest, the controller mixes the contents of the mixing containeragain. In embodiments, this latter mixing may be for a shorterpredefined interval than a predefined interval of operation S210. Thetesting and mixing may be iterated the N number of times and if thefinal test fails, the preparation is halted and a recovery operationinvoked, for example, halting pumping and outputting a display torestart preparation with a new disposable fluid circuit. Through S208 toS212, the contents of the mixing container remain the same as indicatedat 354 and 356.

Proceeding with S214, the osmotic agent is added to the mixing containerand the mixing container contents are mixed at S216. Then a conductivitycheck is performed at S218 with M iterations where M may be any numberincluding equal to N. The quantity of osmotic agent concentrate addedcan be verified at S218 because the combined effect of dilution by thewater constituent and the osmotic agent constituent is to lower theconductivity a measurable amount which depends on how much water andosmotic agent concentrate is added. This decrement in conductivity maybe stored as a predefined quantity by the controller and compared tomeasured levels just as the other conductivity measurements are.

The balance of the required water for achieving the target mixture isadded at S220. At that point the final composition indicated at 364 and366 is obtained. Then, as above, the mixing container contents are mixedat S222 and a conductivity check is performed at S224 with L iterationswhere L may be any number including equal to N or M. In a finaloperation S226 the one or more filters used to protect against touchcontamination (depending on the configuration of the fluid circuit) istested to confirm its integrity during the fluid proportioning.

The reason only a fraction of the water is added initially at S206 isthat mixing initially with part of the water and then again with theremainder of the water may reduce the total mixing time compared toadding all of the water at once at S206. In embodiments, however, mixingall the water at once is a possible alternative embodiment.

In all of the foregoing conductivity measurement operations, theconductivity and the temperature of the fluid may be converted directlyto concentration of the electrolytes in water, or for a fluid thatcontains both electrolytes and an osmotic agent, to concentration ofeither the electrolytes or the osmotic agent, or both. A similar resultmay be achieved by correcting a measured conductivity to account for adifference between a reference temperature and the temperature of thefluid to obtain the conductivity at the reference temperature. A tableof concentrations of the various admixtures vs conductivity at thereference temperature can then be stored in the controller to determinethe concentration for purposes of making corrections in the dialysisfluid composition. In embodiments of disclosed proportioning systems,the reference temperature may be a human body temperature and theproportioning process may include controlling the temperature of thedialysis fluid to be at the body temperature (e.g., 37 C) such that theactual temperature at the time of conductivity measurement is close tothe reference temperature. This makes any errors in the correctedconductivity measurement very small because the actual and referencetemperatures will be close due to the control of the dialysis fluidtemperatures.

In a method embodiment, the constituents are warmed to the deliverytemperature in advance of combining them. In alternative embodiments,the constituents are warmed after combining but prior to testing. Inembodiments, the conductivity is used without compensation forcomparison to reference values. In embodiments, the estimatedtemperature at which concentration or target conductivity is taken is anestimated room temperature. This would be relevant where the combiningis done before warming the product to a temperature for administrationto the patient. Warming to body temperature may be done at a later time.In embodiments, the conductivity levels and associated temperaturecompensation coefficients for each of the expected concentration targetsare taken at 37 C.

FIG. 15B shows, approximately, the relationship between conductivity andconcentration of dextrose during the proportioning procedure describedabove with reference to FIG. 15A. Curves 1506A, 1506B, and 1506Crepresent dilution curves for each of three kinds of dialysis fluidhaving final concentrations of osmotic agent in the finally diluteddialysis fluid. The fully diluted concentrate of each curve mayrepresent, for example, 4.25% dextrose in curve 1506A, 2.5% dextrose incurve 1506B, and 1.5% dextrose in curve 1506C, respectively. The otherconstituents may be the same in all three, i.e., the clinically acceptedcomponents of what is carried in the electrolyte concentrate includingsodium, magnesium, calcium chloride, etc. In other words, at all pointsto the right of the final diluted dialysis fluid (diluted to usableconcentration) are over-concentrated solutions for 4.25%, 2.5%, and 1.5%dialysis fluid. By selecting the ratio of dextrose (osmotic agentconcentrate, more generally) to electrolyte concentrates to be in theproportions of a final dialysis fluid characterized as a 4.25% osmoticagent (dextrose) dialysis fluid, a usable dialysis fluid can be formedwithout the addition of electrolyte concentrate and other dialysisfluids can be formed by adding respective amounts of electrolyte.

Presenting the dilution curves as shown in FIG. 15B highlights what hasbeen pointed out above, namely, that the steps of mixing constituents instages has implications for mixing efficiency and also, as discussednow, for proper measurement of conductivity. The ability to makeunambiguous conductivity measurements varies for different points in thedilution vs. conductivity space. For example, curve 1506A illustratesthe dilution curve for a concentrate with lowest percentage ofelectrolyte to osmotic agent and it can be seen that certainconductivity values indicate two different dilution levels. Alsoindicated at 1508 is a range for efficient mixing. The indications areall figurative and the precise ranges would be determined by experiment.

In the proportioning procedure of FIG. 15A outlined above, themeasurement zones are restricted to a range where conductivity issingle-valued and optimized mixing efficiency regions 1508. Referringalso to FIG. 15A, water S106 is combined with electrolyte concentrateand osmotic agent concentrate S108 and mixed in the mixing container andthe conductivity measured at S112. This corresponds to point 1500 wherethe composition corresponds to 4.25% dextrose that is partially diluted.Next, assume that the target dialysis fluid is 2.5% dextrose dialysisfluid. The addition of electrolyte concentrate S114 brings thecomposition of the mixing container to point 1502 which is on curve1506B which corresponds to an overconcentrated 2.5% dextrose dialysisfluid. The final dilution at S120 brings the composition to the point1504 which is that for ready to use 2.5% dextrose dialysis fluid. Themeasurement points 1500, 1502, and 1504 are all in desirable regions ofthe dilution/conductivity space. In the graph the osmotic agentconcentrate is identified as dextrose but could be other kinds ofosmotic agent concentrate.

In all of the foregoing embodiments, the final product can be obtainedby ratiometrically balanced proportioning, relying purely on therepeatability of volumes delivered by the pumping. In such embodiments,the concentration need not be detected and proportioning can be doneindependently of any concentration measurements. In further embodiments,the final composition can be verified through a single concentrationsampling and measurement.

Referring now to FIG. 15C, a graph shows mixing time versus dextroseconcentration (note that other osmotic agent concentrates may besimilarly represented) with a curve indicating total pumping timerequired to transfer the required full water and concentrate quantitiesand to mix the contents to a point that ensures complete mixing. Thelatter may be determined experimentally by periodically sampling thecontents of a mixing container at times during mixing and identifyingthe time required for full transfer and complete mixing (“pumping time”)as the point where the concentration reads a constant value. The ratioof water and the osmotic agent (e.g., dextrose) concentrate in theinitial combination at 1500 in FIG. 15B may affect the total timerequired to create the admixture including time to pump water andconcentrate and time to mix the container contents. Requiring the point1500 to lie in the range of ratios of water and osmotic agentconcentrate where the concentration measurement is monotonic andrequiring the point to be remote from the solubility limit of theosmotic agent, a minimum pumping time may be identified. Accordingly, anoptimum initial ratio of ratio of masses of osmotic agent concentrateand water may be found and used to define the combination identifiedwith the point 1500 in FIG. 15B. In embodiments of the disclosed subjectmatter, for example the method of FIG. 15D, the point 1500 may bedetermined responsively to these conditions.

Note that in any of the embodiments, the use of peristaltic pumps can bereplaced by metering pumps that employ any of a variety of pumpingmechanisms that may provide sufficient absolute accuracy to satisfy aprescribed treatment (i.e., a ratio of the commanded quantitytransferred to the actual is bounded by a predefined range that furtherfalls within the permitted proportions of the admixture or final productdialysate constituents). This is compared to a pumping mechanism thatrelies on ratiometric accuracy in that the ratio of components isaccurate even if the ratio of commanded-to-actual rates (or volumes) isnot as accurate as the prescribed requirement.

Referring to FIG. 16A, in another method embodiment for creating a batchof dialysis fluid, electrolyte concentrate is pumped into the mixingcontainer before osmotic agent concentrate is added. This allows thetesting and adjustment of the electrolyte concentrate concentration tobe performed on the mixed batch prior to the addition of osmotic agentconcentrate. Because the tolerance of the dialysis fluid prescription tovariation in the electrolyte concentrate concentration is much tighter,for example +/−2.5%, than the concentration of osmotic agent concentrate(+/−5%), the addition, confirmation, and adjustment of electrolyteconcentrate alone allows the proportioning to be more tightlycontrolled. In embodiments, additional water or concentrate may be addedto ensure the concentration is within the electrolyte concentratelimits. In embodiments, the dose of osmotic agent concentrate iscontrolled solely by volumetric control. In embodiments, the quantity ofosmotic agent concentrate added during proportioning is checked with aconductivity measurement but the quantity is not titrated to adjust itbased on conductivity measurements.

The method begins with the pumping of all, or a fraction of the requiredwater for the batch into the mixing container 458. In a variation, aquantity of water equal to a predefined fraction required for the finalbatch is pumped into the mixing container. For example, 50% of thetarget quantity of water may be added. As noted elsewhere, the quantitymay be selected to minimize overall pumping time or at leastresponsively to overall mixing time. Next, 100% of the required dose ofelectrolyte concentrate is pumped into the mixing container 459. Themixing container contents are then mixed at 460 and a sample of themixing container is withdrawn and tested at 461 by pumping a samplethrough one or more conductivity sensors, for example as described inthe above embodiments. At 463, the osmotic agent concentrate dose ispumped into the mixing container and the batch contents are mixed 464.Mixing here, and in all method embodiments, may be done by any of themechanisms identified above or by any suitable method.Magnetohydrodynamic mixing (excitation circuits may be provided, formixing and/or for warming, in a support for the mixing container) may beemployed here to reduce the count of roller strikes on the fluid circuitthat would otherwise occur if pump mixing were used. A sample may bepumped from the mixing container and tested at 465 by pumping a samplethrough one or more conductivity sensors, for example as described inthe above embodiments. If additional water is required, depending on theamount originally added at 458, then the final balance of water ispumped into the mixing container at 467 and the final dilutedconcentration check as at 465 is done at 468.

At 469 a pressure test of one or more sterilizing filters depending onthe embodiment (e.g., 115 of any FIG. 1A-1D, 2A, 2E or 2H) may beperformed and a result of the test may be made a condition for therelease of the batch for a treatment. That is, in the method, all fluidsadded to the batch that are not otherwise preconnected to the mixingcontainer (as done in some but not all disclosed embodiments) may havean inline sterilizing filter preconnected between the outside source andthe mixing container. That is, the sterilizing filter is preconnectedsuch that its sterilizing filter membrane defines a barrier to theinterior of the mixing container such that any touch contaminationresulting from the making of a connection to the mixing container isblocked by the filter membrane when a fluid transfer occurs through themade connection. When the sterilizing filter or filters is/are pressuretested—that is, one or more sterilizing filters relied upon to definethe sterile barrier are pressure tested—the controller makes adetermination as to whether they have passed the pressure test and theneither prevents or permits the batch to be used. In a method, thecontroller generates a message indicating the outcome of the pressuretest or tests. The controller may generate the message to be output on adisplay along with an indication that the batch is not permitted to beused. The controller may further prevent the transition to a treatmentmode in which the batch is used. The controller may, in an alternativeembodiment, transition to a mode for preparation of a new batch. Thecontroller, in the latter case, may output an instruction to replace afailed disposable with a new one and to initiate preparation of a newbatch.

At 461, 465, and 468, the conductivity of the mixing container isdetected and compared to an expected value in order to ensure theproportioning process is proceeding correctly. If a comparison to anexpected value stored in a controller fails to pass, a recoveryprocedure may be performed as described with reference to FIGS. 15A and15D, that is, the batch may be mixed (for any time, or for an intervalshorter or equal to a mixing time of 460) and the batch contents sampledand tested again. Thus, one form of recovery is to recover from aninvalid test rather than a bad mixture. If, after some predefined numberof remix/test attempts, the conductivity differs from the storedexpected value by more than a predefined amount or percentage, theproportioning process may stop, and the controller may output a messageto restart the proportioning process. In addition to stopping theproportioning process, the controller may prevent access to the batch byclamping a line or take some other safety precaution to prevent misuseof the failed batch contents.

An additional recovery process may be implemented by the controller toadjust the conductivity of the batch in a way that corrects for a mixingerror. When a conductivity test fails, i.e., the measured conductivityis outside a predefined range with respect to a stored expected value,the controller may adjust the proportions of the batch by adding wateror one or both concentrates in an amount that is in response to themagnitude of the error. As an initial operation, the controller maycompare the magnitude of the error in combination with the stage ofproportioning in order to determine if an adjustment is permitted. Inembodiments, the controller stores a respective error magnitude range ofconductivity for each test (461, 465, and 468). The stored errormagnitude, which may be different for negative and positive errors, maybe compared with a detected error at 461, 465, or 468 and the controllermay proceed with an adjustment process if the error magnitude is belowthe stored error magnitude or terminate proportioning if not. The errormagnitude may be advantageously based on the last remix/test cycle forthe particular operation 461, 465, or 468.

The recovery procedure may also employ a scale that measures the weightof the disposable unit. The disposable unit includes a mixing containerand one or more concentrate containers depending on the embodiment. Onlywater is added and it is added to the mixing container. After obtaininga baseline weight after the disposable unit is rested on a scale,thereafter the quantity of water added to the mixing container can bedetected by weight. No change in the total weight of the disposable unitoccurs when concentrate is transferred to the mixing container. Usingthe conductivity plus the weight of the disposable unit, at eachoperation 461, 465, or 468, the controller can determine precisely theamount of added water or concentrate needed to achieve the targetratios.

In embodiments without a scale, or in which a scale is not used forproportioning control, the controller may perform operations as followsto recover by changing the mixing container contents to correct for anerroneous reading. Referring to FIG. 15E, a flow chart is shown inoutline form. It repeats elements of other mixing methods presented herebut is not a separate embodiment in that it can be added (withsubstitution, as necessary) as a conductivity error recovery method toany of the methods presented herein.

Referring to FIG. 15E, at 1.0 an initial water dose is added to themixing container. At 2.0 a first concentrate is added, which can be, forexample, osmotic agent concentrate or electrolyte concentrate accordingto any of the embodiments. At 3.0 the batch contents are mixed and at4.0, the conductivity is measured. At 4.1 the controller determines ifthe conductivity measurement matches, within a predefined tolerance, theexpected value and if so, operation proceeds to 5.0. Otherwise, at 4.2,an error recovery method 4.2.1 calculates an actual first concentrate inthe batch by assuming that the correct quantity of water was pumped intothe container. This may be obtained because the relationship betweenconcentration and conductivity is stored. This relationship can bestored as a lookup table, a power function fitted formula, or some otherway to allow a new quantity of concentrate to be calculated from thegiven water quantity and the calculated concentration of the firstconcentrate. The new quantity of concentrate (e.g., volume, but theunits of the computation are not essential) is used to calculate a newtarget quantity of the second concentrate at 4.2.2.

At 5.0 the second concentrate is added, mixed 6.0, and the batchcontents conductivity measured 7.0. If the conductivity value matchesthe expected conductivity based on the reset volume transfer ofconcentrate from 4.2.2 if this operation was performed previously, thencontrol proceeds to 8.0. If the conductivity is erroneous and waspreviously erroneous for the first concentrate, then at 7.2 then theproportioning process is terminated and a recovery process initiated.The batch is a failed batch at this point. Control reaches 7.3 if theconductivity measurement at 4.0 was in range and the conductivitymeasurement at 7.0 was not in range. At 7.3.1 if the conductivityindicates deficiency of the second concentrate was added to the batchcontainer at 5.0, then an additional amount to be added is calculatedbased on the magnitude of the conductivity measurement and thereafteradded to the mixing container. Control proceeds to 7.3.2.1. At 7.3.1 ifthe conductivity indicates a surfeit of the second concentrate was addedto the mixing container at 5.0, then an additional amount the firstconcentrate and water to be added are calculated based on the magnitudeof the conductivity measurement and thereafter added to the mixingcontainer. At 7.3.2.1 the batch contents are mixed and conductivitymeasured again at 7.3.2.2. If the measurement is within expected range,then at 7.3.2.2.1 control proceeds to 8.0; otherwise the proportioningis terminated at 7.3.2.2.2.

If no hard termination of the proportioning has occurred, then at 8.0the balance of the water is added, at 9.0 the mixing container contentsare mixed, and at 10.0 the conductivity of the batch fluid is measured.If the measurement is good, at 10.1, then control proceeds to 11.0. Ifthe conductivity measurement is within the expected range, then controlproceeds to 11.0, otherwise control proceeds to 10.1.1 or 10.1.2 basedon whether the conductivity measurement indicated under-dilution orover-dilution at 8.0. If over-dilution is indicated by the conductivitymeasurement (i.e., measured conductivity is lower than the expectedthreshold) then at 10.1.1 both concentrates are added in the prescribedratio as described in the present disclosure. If under-dilution isindicated at 10.1.2, water is added as described in the presentdisclosure. In both cases, the water deficit or surfeit can be estimatedfrom the conductivity measurement based on the prescribed quantities ofthe concentrate constituents with any adjustments stored due topreceding recovery operations. In this final adjustment stage it ispossible to add water or concentrates in increments and test repeatedlyto titrate the batch contents to a final target level of conductivity.At 10.1.2.1 the batch contents are mixed and conductivity measured againat 10.1.2.2. If the measurement is within the expected range, then at10.1.2.2.1 control proceeds to 11.0; otherwise, the proportioning isterminated at 10.1.2.2.2.

At 11.0, the filter or filters that ensure sterility of all fluidsis/are tested and if the test fails, the batch is terminated asdiscussed above. Otherwise the batch is released at 12.0.

Note that in all the relevant operations in FIG. 15E, a magnitude of theerror between the expected value of conductivity and the measured valueis compared to a permitted range and if outside that range, control mayproceed to a hard termination of the proportioning, as in 7.2, forexample and as described elsewhere.

FIG. 17A shows a proportioning and treatment system for peritonealdialysis 700A. Two multi-treatment containers 736 and 738 containelectrolyte concentrates and osmotic agent concentrates, respectively.They are connected by aseptic connectors 730 to a fluid circuit 701A byrespective osmotic agent concentrate 744 and electrolyte concentrate 742lines. Non-aseptic connectors may also be used. In embodiments, wherethe connectors are non-aseptic, the osmotic agent concentrate 744 andelectrolyte concentrate 742 lines may contain sterilizing filters. Dueto the cost and number of filters required this is not a preferred wayto ensure sterility. A last fill container 734 may also be connected tothe fluid circuit 701A via last fill line 740. The last fill container734 may contain a specific medicament for the last fill cycle of amulti-cycle treatment. The fluid circuit 701A contains first 758 andsecond 760 manifolds connected by a pumping tube 763. The manifolds 758and 760 define selectable fluid paths connecting various sources offluids to fluid consumers using clamps 751 under control of a controller739. The details of the flow switching may be as discussed above withrespect to similar embodiments. A purified water source 766 suppliespurified water to the manifold 758 through redundant sterilizing filters731. The filters 731 may be replaced by a single testable filter that isautomatically tested to confirm that a batch is sterile as described inmethod embodiments in the present disclosure. Manifold 760 is connectedby a drain line 756 to a drain line circuit 765 through a non-asepticconnector 729. The drain line circuit has a conductivity sensor 764 inits path to permit the measurement of conductivity of samples of fluidconveyed through the manifold 760 under control of the controller 739.The mixing container 732 is connected by inlet and outlet lines 746 and750 to the manifolds 758 and 760, respectively, to allow fluid to bepumped into the mixing container 732, to be drawn from the mixingcontainer 732, and to permit mixing via recirculation of the contents ofthe mixing container 732. A pump 762 pumps fluid between the manifolds758 and 760. Pressure sensors 769 are positioned on either side of thepump 762 to detect pump inlet and outlet pressures in pump tube 763.Signals corresponding to the pressures are applied to the controller 739and used for pump pressure compensation and/or pump calibration asdiscussed elsewhere and in US Patent Publication 2015-0005699, herebyincorporated by reference in its entirety herein. A waste container 768may be attachable to the drain line circuit 765 by a non-asepticconnector 729. A heater 770 contacts the mixing container 732. Inembodiments, the heater 770 forms a bed on which the mixing container732 rests. A patient line 754 is connected by a Y-connector to separatelines 748 and 752 to permit the filling and draining of a patient 718through the patient line 754, which is connected to a catheter (notshown) by means of another aseptic connector 730.

The fluid circuit 701A connects to proportioning/cycler machine 772 by amechanism that aligns clamps 751 with respective clamping portions oflines 741, 740, 742, 744, 750, 746, 752, and 756. Various suchmechanisms are known in the art such as supports that hold tubingportions at predefined positions in cassettes and cartridges and compactfluid circuits that can be easily laid over a set of actuators andsensors. The manifolds and clamps can be replaced by a variety ofdifferent types of flow selector devices known in the art, so thecurrent system is not limited to using flow selectors based on clampingof tubing. If the pump 762 is a peristaltic pump, a pumping tube segmentof line 763 may be aligned by the connection of the fluid circuit 701A.The purified water source 766 may be housed in an enclosure 767 togetherwith the drain line circuit 765 or portions of either. The wastecontainer 768 may be housed in the same enclosure, or not, asillustrated. The concentrate containers 736 and 738 may containsufficient concentrate for multiple fill/drain cycles, multiple days'worth of treatments, each consisting of multiple fill/drain cycles, aweek's worth of treatments, a month's worth of treatments, or some otherschedule. The concentrate containers 736 and 738 may be independentlyreplaceable by use of the aseptic connectors. The benefits ofindependent replacement are discussed elsewhere in the presentdisclosure. The contents of the last fill medicament container 734 maybe fully diluted or may consist of, or include, a concentrate thatrequires further dilution. The manifolds 758 and 760 may have a minimumvolume to reduce waste when changing over fluids. In embodiments, themaximum hydraulic diameters of the manifolds 758 and 760 are each nomore than 5 times the diameter of the largest line connecting to them.In further embodiments, they are no more than 3 times the diameter ofthe largest line and in still further embodiments, no more than twice.

Referring to FIGS. 16B and 17A, in a method for creating a batch ofdialysis fluid, a set of priming operations is first performed. Theoperations 485, 486, 487, 488 and 489 collectively form an overalloperation sequence that fills osmotic agent concentrate, electrolyteconcentrate and last fill lines 740, 742, and 744 with the respectivefluids and fills the mixing container 732 inlet 746 and outlet 750 linesas well as the manifold 758, pumping tube 763, manifold 760, and waterline 741 with purified water. The operations can be in any order but inparticular embodiments, the water is primed through the manifold last.

At 485, a first concentrate 736 or 738 is conveyed to the wastecontainer 768 (which can be a sewage drain rather than a container) byclosing the valves 751 for all of the lines except for the valves 751that permit flow through the respective concentrate line 742 or 744 andthe valve 751 that permits flow through the drain line 756. The pump 762is operated to establish a flow until a predefined condition is met. Thepredefined condition may be detected by the controller 739. Thepredefined condition may be a detected volume of concentrate determinedby the controller 739, a number of cycles (e.g., rotations) of a pumpactuator, or a detected conductivity or rate of change thereof,indicated by the conductivity sensor 764. The condition may be selectedto ensure that the respective concentrate line 742 or 744 is filled. Thecondition may be further selected to ensure that the respectiveconcentrate line 742 or 744 is purged of any air. The absence of any airin the respective concentrate line 742 or 744 may be established by anair detector, for example one that is located at the conductivity sensor764 or located elsewhere along the path. The condition may include acombination of a threshold level of (or no) detected air combined with apredefined threshold of conductivity.

At 486, a second concentrate 736 or 738 (other than the firstconcentrate) is conveyed to the waste container 768 (which can be asewage drain rather than a container) by closing the valves 751 for allof the lines except for the valves 751 that permit flow through therespective concentrate line 742 or 744 and the valve 751 that permitsflow through the drain line 756. The pump 762 is operated to establish aflow until a predefined condition is met. The predefined condition maybe detected by the controller 739. The predefined condition may be adetected volume of concentrate determined by the controller 739, anumber of cycles (e.g., rotations) of a pump actuator, or a detectedconductivity or rate of change thereof indicated by the conductivitysensor 764. The condition may be selected to ensure that the respectiveconcentrate line 742 or 744 is filled. The condition may be furtherselected to ensure that the respective concentrate line 742 or 744 ispurged of any air. The absence of any air in the respective concentrateline 742 or 744 may be established by an air detector, for example onethat is located at the conductivity sensor 764 or located elsewherealong the path. The condition may include a combination of a thresholdlevel of (or no) detected air combined with a predefined threshold ofconductivity.

At 487, a last fill (either a concentrate or a ready for use medicament)is conveyed to the waste container 768 (which can be a sewage drainrather than a container) by closing the valves 751 for all of the linesexcept for the valves 751 that permit flow through the last fill line740, and the valve 751 permits flow through the drain line 756. The pump762 is operated to establish a flow until a predefined condition is met.The predefined condition may be detected by the controller 739. Thepredefined condition may be a detected volume of fluid determined by thecontroller 739, a number of cycles (e.g., rotations) of a pump actuator,or a detected conductivity or rate of change thereof indicated by theconductivity sensor 764. The condition may be selected to ensure thatthe last fill line 740 is filled. The condition may be further selectedto ensure that the last fill line 740 is purged of any air. The absenceof any air in the last fill line 740 may be established by an airdetector, for example one that is located at the conductivity sensor 764or located elsewhere along the path. The condition may include acombination of a threshold level of (or no) detected air combined with apredefined threshold of conductivity.

At 488, purified water is conveyed to the waste container 768 (or sewagedrain) by closing the valves 751 for all of the lines except for thevalves 751 that permit flow through the water line 741 and the valve 751that permits flow through the drain line 756. The pump 762 is operatedto establish a flow until a predefined condition is met. The predefinedcondition may be detected by the controller 739. The predefinedcondition may be a detected volume of water determined by the controller739, a number of cycles (e.g., rotations) of a pump actuator, or adetected conductivity or rate of change thereof indicated by theconductivity sensor 764. The condition may be selected to ensure thatthe water line 741 is filled. The condition may be further selected toensure that the water line 741 is purged of any air. The absence of anyair in the water line 741 may be established by an air detector, forexample one that is located at the conductivity sensor 764 or locatedelsewhere along the path. The condition may include a combination of athreshold level of (or no) detected air combined with a predefinedthreshold of conductivity.

At 489, an optional step is performed of recirculating the water throughthe mixing container 732. In embodiments, this may be done before or inthe middle of the operation at 488 as well as after. The valves 751opening inlet line 746 and the valve opening water line 741 are openedwhile all other valves 751 are closed so that when the pump 762 isoperated, water is pumped into the mixing container 732. Then the waterline 741 valve 751 is closed and the outlet line 750 valve 751 is openedso that when the pump 762 runs, water can be continuously recirculatedin the mixing container 732. The controller implements this flowconfiguration for a predetermined number of pump cycles or a predefinedtime (which may depend on the flow rate). This operation breaks in thepump tube 763 for a peristaltic pump, thereby making the relationshipbetween pump cycle rate (e.g., RPM) and flow rate more consistent. Thisoperation is beneficial when a new fluid circuit 701A is installed.After the pump tube 763 break-in is completed, the inlet line 746 may beclosed by the respective valve 751 and the drain line 756 opened by therespective valve, after which the pump 762 operates to drain the mixingcontainer. Whether the pump break-in is completed after, before, orduring priming of the manifold and drain line with water, the operationserves to prime the inlet 746 and outlet 750 lines and further prime thedrain line 756 and manifolds 758 and 760.

Note that instead of a conductivity detector at 764, other types ofsensors may be used to detect the filling of the respective concentrateline. For example, a flow sensor may be responsive to the density orviscosity of fluid flowing in the drain line 756. Another alternative isa temperature sensor for cases where the temperature of the fluidreaching the sensor is different from the fluid being displaced.

In the embodiment of FIG. 16A, electrolyte concentrate is pumped intothe mixing container before osmotic agent concentrate is added. However,in alternative embodiments, osmotic agent concentrate (which may containelectrolytes that function as a marker) is added to the mixing containerbefore the remaining electrolyte concentrate. The method begins with thepumping of 100% or less of the required water for the treatment batchinto the mixing container 732. By closing all valves 751 except thoseclosing water line 741 and inlet line 750, a predefined volume of wateris pumped by the pump 762 from the purified water source 766 throughsterilizing filters 731 (or a single testable filter if present),through the optionally aseptic connector 730, through water line 741,manifold 758, through pumping tube 763, into manifold 760, throughmixing container inlet line 746, and into the mixing container 732. Thevolume displaced may be controlled by the controller by controlling thenumber of cycles of the pump 762 to a predefined number of cycles (e.g.,rotations of a peristaltic pump). The embodiment of FIG. 16B can bemodified in a similar manner, however, the osmotic agent concentratepumped into the mixing container first, may contain electrolyteconcentrate in sufficient quantity to serve as a marker in order to testthe admixture at 473.

For purposes of accounting for the precise quantities of fluids that arepumped into the mixing container 732, the controller's operations to thepump 762 are such that displacement of residual volumes of fluidsremaining in respective parts of the fluid circuit are accounted for. Inoperation 470, the total quantity entering the mixing container is equalto the quantity displaced by the pump 762 in this operation because themanifolds 758 and 760 and the inlet line 746 were previously primed. So,no additional accounting is reflected in the control of the pump in thatcase. The pump is operated to displace a target volume of water and thecontroller can be programmed to do calculations based on the batchvolume being equal to the displaced volume during operation 470. Forconvenience in discussing the further operations where displacement of afluid also displaces another remaining in the fluid circuit 701A, thefollowing identifiers will be used:

MIMO, for the combined volume of the manifold 758, pump tube 763, andmanifold 760;

MOTI, for the volume of the inlet line 746 between the mixing container732 and the manifold 760;

SOMI, for the volume of the outlet line 750 between the mixing container732 and the manifold 758.

At 471, electrolyte concentrate from electrolyte concentrate container736 is pumped to the mixing container 732 by opening respective valves751 for the electrolyte concentrate line 742 and the inlet line 746 andclosing other valves 751 to form a direct path that includes MOTI andMIMO. The electrolyte concentrate is pumped by the pump 762 from theelectrolyte concentrate container 736, through the manifold 758 byopening only the clamp 751 that closes the electrolyte concentrate line742. The pump draws the electrolyte concentrate from manifold 758through the pump tube 763 and into manifold 760 through the inlet line746 into the mixing container 732. A volume equal to 100% of therequired dose of electrolyte concentrate is pumped toward the mixingcontainer 471 but a predetermined fraction equal to MOTI and MIMOremains behind. In addition, through the pumping of electrolyteconcentrate, a volume of water equal to MOTI and MIMO is added to themixing container 732. The controller uses a predetermined conductivitythreshold for a mixed diluted electrolyte concentrate based on the addedvolume MOTI plus MIMO of water. This conductivity threshold allows thetesting at 473 and adjustment at 474 of the electrolyte concentrateconcentration to be performed on the mixed batch prior to the additionof osmotic agent concentrate with the concomitant tolerance benefitsdiscussed above.

The mixing container contents are then mixed at 472 by closing allvalves 751 except those closing the inlet 746 and outlet 750 lines tothe mixing container 732 such that fluid is circulated into and out ofthe mixing container 732. As a result, the fraction of electrolyteconcentrate equal to MOTI and MIMO is integrated into the batch contentsand the water left in SOMI is integrated in as well. For concentrationmeasurement purposes the total pumped volume of concentrate conveyed at471 is mixed with the total pumped volume of water conveyed at 470 withthe additional dilution of a SOMI volume to determine the expectedconcentration. A sample of the mixing container is withdrawn and testedat 473 by pumping a sample through one or more conductivity sensors, forexample as described in the above embodiments. This is done by closingall the valves 751 except for those controlling the outlet line 750 andthe drain line 756 and operating the pump 762 to convey a predeterminedvolume of fluid from the mixing container 732 to the conductivity sensor764. The controller 739 may account for the drained volume in makingadjustments to its internal model of the batch contents at 474 includingtotal volume and proportions of constituents. The concentration ofelectrolyte concentrate can be determined by the controller 739 by theconductivity measurement permitting the controller to add more water orelectrolyte concentrate to change the concentration to fit a target.Alternatively, the internal model of composition of the mixing containerstored by the controller 739 may be adjusted responsively to themeasurement and accounted for later to change the amount of osmoticagent concentrate and/or water added to the mixing container 732 inlater operations to generate the target prescription fluid. At 474, ifthe batch contents are adjusted immediately and responsively to theresults of the concentration test, then water or additional electrolyteconcentrate may be pumped into the mixing container 732 using the valve751 settings identified above, depending on whether the concentrationmeasurement indicated over-dilution or under-dilution. If less than 100%of the water dose is used in 470 (as in the embodiment variationidentified above), then additional water may be added up to therequirement per prescription. Again, such a water balance may be addedafter 475 and 454 at 455.

At 475, osmotic agent concentrate from osmotic agent concentratecontainer 738 is pumped to the mixing container 732 by openingrespective valves 751 for opening the osmotic agent concentrate line 744and the inlet line 746 and closing other valves 751 to form a directpath that includes MOTI and MIMO. The osmotic agent concentrate ispumped by the pump 762 from the osmotic agent concentrate container 738,through the manifold 758 by opening only the clamp 751 that control theosmotic agent concentrate line 744 and the inlet line 746. The pumpdraws the osmotic agent concentrate from manifold 758 through the pumptube 763 and into manifold 760 through the inlet line 746 into themixing container 732. A volume equal to 100% of the required dose ofosmotic agent concentrate is pumped toward the mixing container 471 buta predetermined fraction equal to MOTI and MIMO remains behind. Therequired dose may be determined, in part, by the results of theconductivity test at 473 as indicated above. The volume transferred mayalso account for the volume of diluted electrolyte concentrate of theprior batch contents which remains in MOTI and MIMO before the osmoticagent concentrate is pumped. Finally, the residual volume is transferredto the mixing container 732 in the final dilution at 455, if present,such that the volume of osmotic agent concentrate transferred to themixing container 732 is in part compensated to account for thatadditional volume. The batch contents are mixed using the valve settingsidentified in the discussion of operation 472. This mixes-in theresidual MOTI and MIMO volumes of osmotic agent concentrate remainingbehind after pumping the osmotic agent concentrate, as well as the SOMIvolume of the mixture, before addition of osmotic agent concentrate.

At 454, the batch contents may be sampled as discussed in relation tothe operation 473 by setting appropriate valves 751 and operating thepump 762. The conductivity determined from the sample indicates to thecontroller whether the batch is good and can be used for a treatmentcycle or whether it is bad and should be drained and remade or someother recovery cycle implemented. The addition of osmotic agentconcentrate and associated water has a measurable effect on theconductivity. The addition of osmotic agent concentrate, depending onthe specific type (dextrose, for example), tends to lower theconductivity. However the concentrate impacts the conductivity, it canbe predetermined and stored by the controller so that the conductivitymeasurement at 454 can be used to determine if the conductivitycorresponds to the internal model or is outside a predefined rangethereabout. As stated, the controller will enable the batch to be usedfor a treatment or regenerated or it will prevent usage by preventingthe advance of the control system to treatment mode, generate an errorsignal, drain and generate a new batch, or any combination thereof,based on the conductivity result.

At 455, if less than 100% of the required water for a complete batch wasadded to the mixing container 732 at 470, then the remaining complementof water is added at 455 using the settings described above with regardto operation 470. The total amount of water displaced is ultimatelyadded to the batch, even though a fraction remains behind initially inMOTI and MIMO. This is because of the additional mixing operation at476, where the MOTI and MIMO portions are mixed into the batch. The SOMIvolume of the previous mixture attained at the end of 475 is also mixedin.

At 475, an osmotic agent concentrate volume is transferred to the mixingcontainer 732. A dose is pumped into the mixing container 732 and thebatch contents are mixed. At 454 the conductivity of the batch contentsis measured and if it is within limits, control moves on to 455, and ifnot, the proportioning is terminated. At 455, if less than 100% of thewater was added at 470, then the final volume of water is added to themixing container 732. At 476, the batch contents are mixed and the MOTIand MIMO volumes of water are mixed in as well as the prior mixture fromSOMI to form the final mixed batch. At 456, the conductivity is testedusing the procedure described above in reference to 473. At 457, anysterilizing filters responsible for ensuring sterility of fluids may betested or redundant filters may be used. If the filter(s) integrityis/are confirmed, then the batch will be released; otherwise, the batchis not released. The possible responses to an out-of-range reading ofconductivity may be as described with reference to operation 454.

Referring to FIG. 16C, in a further embodiment, suitable for a pumpingsystem and/or method that provides a high degree of volumetric accuracy,water and osmotic agent concentrate and electrolyte concentrates aretransferred to the mixing container and mixed 477-481 in a single set ofoperations relying on volumetric control. At 477 100% or a fraction of atarget water volume is pumped into the mixing container. At 478, 100% ofa target volume of electrolyte is transferred to the mixing container.At 479, a volume of osmotic agent is pumped into the mixing container.At 480, if less than 100% of the water was transferred at 477, then acomplementary quantity of water is added to bring the total to 100%. At480 the conductivity of the mixing container contents can be measuredand if necessary additional water added. Conductivity is measured aftermixing. At 481 the mixing container contents are mixed. The operationsmay be followed by a pressure test of a sterilizing filter as discussedwith reference with the other embodiments.

FIG. 17B shows a proportioning and treatment system for peritonealdialysis 700B. Two multi-treatment containers 736 and 738 containelectrolyte concentrates and osmotic agent concentrates, respectively.They are connected by aseptic connectors 730 to a fluid circuit 701B byrespective osmotic agent concentrate 744 and electrolyte concentrate 742lines. Non-aseptic connectors may also be used. In embodiments where theconnectors are non-aseptic, the osmotic agent concentrate 744 andelectrolyte concentrate 742 lines contain sterilizing filters. Due tothe cost and number of filters required this is not a preferred way toensure sterility. A last fill container 734 may also be connected to thefluid circuit 701B via last fill line 740. The last fill container 734may contain a specific medicament for the last fill cycle of amulti-cycle treatment. The fluid circuit 701B contains first 758 andsecond 760 manifolds connected by a pumping tube 763. The manifolds 758and 760 define selectable fluid paths connecting various sources offluids to fluid consumers using clamps 751 under control of a controller739. The details of the flow switching may be as discussed above withrespect to similar embodiments. A purified water source 766 suppliespurified water to the manifold 758 through redundant sterilizing filters731. The filter 733 is a single testable filter that is automaticallytested by pumping air by means of an air pump through an air line 737and measuring pressure, detecting whether the filter's bubble point hasbeen exceeded, and if not, confirming the integrity of a filter membraneof the filter 733. Alternative filter integrity tests may also beprovided such as a pressure decay test. The test of the filter 733 isused by the controller 739 to confirm that a batch is sterile asdescribed in method embodiments in the present disclosure. Manifold 760is connected by a drain line 756 to a conductivity sensor module 714through a non-aseptic connector 729. The conductivity sensor module 714is a replaceable component interconnectable between outlet manifold 760and a waste container 768 (or a waste outlet such as a drain). Theconductivity sensor module 714 has a pair of conductivity sensors 764 ina drain channel 715. The conductivity sensors 764 provide independentindications of conductivity that can be compared to indicate a badsensor and/or to provide a mechanism for flow sensing based on a time offlight of a conductivity perturbation in the flow through the drainchannel 715. The conductivity module 714 engages with theproportioning/cycler machine 772 which houses a valve actuator 721. Thelatter is not replaced when the conductivity module 714 is replaced. Theconductivity module 714 can be a low cost component by employing plasticconductivity cells, a tube with connectors and a pinching portiondefining a valve 751 by separating the valve actuator 721 (the one shownthat controls flow through the drain channel 715) from the tube pinchingportion and selecting a low cost arrangement for the conductivity cells764, the tubing forming the drain channel 715, the connectors 729 and ahousing or support indicated at 714.

A mixing container 732 is connected by inlet and outlet lines 746 and750 to the manifolds 758 and 760, respectively to allow fluid to bepumped into the mixing container 732, to be drawn from the mixingcontainer 732, and to permit mixing via recirculation of the contents ofthe mixing container 732. A pump 762 pumps fluid between the manifolds758 and 760. A waste container 768 may be attachable to the drain linecircuit 765 by a non-aseptic connector 729. A heater 770 contacts themixing container 732. In embodiments, the heater 770 forms a bed onwhich the mixing container 732 rests. A patient line 754 is connected bya Y-connector to separate lines 748 and 752 to permit the filling anddraining of a patient 718 through the patient line 754, which isconnected to a catheter (not shown) by means of another asepticconnector 730.

In all embodiments, 17A through 17D and others, a sampling arrangement,now described, may be provided. Although not shown in FIG. 17A, a sampleline may be provided stemming from header 760. Referring to theembodiment of FIG. 17D presently, the sample line 774 is connected to asample container 773 through a non-aseptic connector 729. A valve 751controlling flow through the sample line 757 is controlled to samplefluid from the header 760 automatically by the controller 739. Inembodiments, a temperature of draining dialysis fluid is monitored for acondition indicating an infection or some other condition for which asample may be automatically drawn and stored during draining accordingto the condition. See US Patent Publication US20150005699, incorporatedby reference elsewhere herein and International Patent PublicationWO2018045102, for details of how parameter monitoring of the spentdialysis fluid may be used to detect a condition.

In traditional peritoneal dialysis systems, all of the patient effluentis collected in a large sample bag which may contain, for example, 10 ormore liters of fluid. In the present embodiments, small samples (lessthan the total amount of effluent, are routed to a small volume samplecollection container. Thus, an aliquot from each patient drain cycle maybe generated automatically in a small container (e.g., ˜200 ml, forexample, but it could be less or more). The collection container may bea bag. At the end of a treatment, the system controller may outputinstructions for removing, sealing, and delivering the collected sample.For example, the container may be delivered to the patient's dialysiscenter which would analyze it to assess the adequacy of therapy.

According to a method, the following control scheme may be implementedby the proportioner/cycler controller 739. The controller 739 firstinitiates a drain cycle of a predefined number of drain cycles of anentire treatment. A command indicating the aliquot volume or mass may begenerated and used to control the pump 762 of the proportioner/cycler. Acommand may also be generated to indicate an initial volume or mass topass to waste container or drain 768 before beginning a diversion of thedrain flow while metering the size of the cumulating sample and thenswitching valves 751 to a configuration where the spent peritonealdialysis fluid is sent to waste container or drain 768. The sequence maybe implemented using valves 751 and pump 762. The process of switchingbetween patient line 754 to waste container or drain 768 and patientline to sample container 773 may include halting the pump while therelevant valves 751 are activated and deactivated to define the correctflow path. The volume that is drained before the aliquot is transferredto the sample container 773 may be determined by how long it takes toclear any residual fluid (fresh peritoneal dialysis fluid, for example)in MIMO. In embodiments, the sample container 773 may be changed at eachdrain cycle in order to collect samples representative of multiplecycles of a single treatment. The controller may also permit sampling tobe done in a manner that acquires multiple fractions throughout thedrain cycle to be stored in the sample container 773 by repeatedly, overmultiple instances, diverting to drain and diverting to the samplecontainer 773. This may allow for the sample to better represent thecomposition of the entire drain volume which may change through thedrain cycle. These fractional samples can also be stored in separatesample containers 773. Parameters of collection, which may be set by thepatient, nurse, or physician accessing the controller 739 locally orremotely, include:

-   -   The volume of the sample;    -   Spacing of samples (for example 1 spacing would be a sample for        each drain cycle and 2 spacing would refer to every other drain        cycle);    -   For spaced samples, the first drain cycle to start sampling;    -   The volume to be discarded before beginning the diversion to the        sample container 773;    -   The days on which to take one or more samples and according to a        predefined cluster of the listed parameters;    -   A permitted number of reschedulings of samplings;    -   A schedule of samplings by date, day of week, day of month, or        number of times per time interval;    -   The number of samples per drain cycle;    -   The number of samples per treatment; and    -   The flow rate of draining.

The controller 739 may store a specific schedule for the taking ofsamples, for example a particular day of the week. The controller 739may output a reminder for the benefit of an operator or patient to letthat person know of an imminent scheduled sample so that the user canprepare. For example, the system may let the patient know that today isa day to take a sample. The notification can be attended, or followed,by an input control that accepts input indicating whether the patientdesires to override, comply, or reschedule. The controller 739 mayreschedule automatically in the event the patient or other user fails toacquire samples or overrides. The controller 739 may store a guidedinstruction script for helping the user to set up and store samplesafter acquisition. The guided instruction may be stored on a web serverand displayed on the proportioner/cycler through a browser so that thescript can be updated centrally. The guided instruction may be promptedupon entry of a user command indicating that the user will perform ascheduled or unscheduled sampling procedure.

Referring now to FIG. 26A, an proportioning and treatment system forperitoneal dialysis 700G has a fluid circuit 705 that is identical to701B except for the connection of a medication container 759 at port 730or port 729. Connections at both are shown but it should be understoodthat it may be that only one may be connected at a given time and theports 730 and 729 may otherwise be used for the purpose described above.Medication container 759 may contain a medication (e.g., antibiotics),an anticoagulant, or other substance to be mixed with peritonealdialysis fluid. The substance may be mixed with the contents of themixing container 732 in an automated way.

Referring to FIG. 26B, at S900 the substance container 759 is connectedto the first manifold 758. Then at S902 the mixing container 732 isfilled by preparing a dialysis fluid. Then at S904 the valve 751 isopened and the pump operated to draw the substance from substancecontainer 759 into the mixing container 732. Then at S906, the pumprecirculates the contents of the mixing container 732 in a recirculatingmixing mode to mix the substance with the dialysis fluid.

Referring to FIG. 26C, at S908 the substance container 759 is connectedto the second manifold 760. Then at S914 the mixing container 732 isfilled by preparing a dialysis fluid. Then at S916 the valve 751 isopened and the pump operated in reverse to draw the substance fromsubstance container 759 into the mixing container 732. Then at S918, thepump recirculates the contents of the mixing container 732 in arecirculating mixing mode to mix the substance with the dialysis fluid.

Referring to FIG. 23, in embodiments, the drain is replaced by acontainer connected to a scale 771 that generates a weight indicationthat is stored by the controller 739. This total weight can be combinedwith a detected measure of the volume captured in the same container 773to provide a cumulative total mass of collected peritoneal dialysisfluid. For example, the total mass can be taken as an average of themass calculated from weight and the mass calculated from volumetricmeasurement. These data may be associated by a code with a code readfrom the sample container 773 such as by means of a bar code, smartchip, RFID tag, or other means. The data indicative of cumulative totalmass estimate may be uploaded to a web site for a laboratory with datarepresenting the sample container 773 code. Alternatively, a chipattached to the sample container 773 may hold the cumulative mass dataso that when shipped to a laboratory, the data can be read by theworkers analyzing the samples. In embodiments, the sample container 773and the waste container 768 can be attached to the scale 771 or may beformed as a single disposable unit with the sample bag portion beingdetachable from the waste container 768.

The fluid circuit 701F connects to proportioning/cycler machine 772 by amechanism that aligns clamps 751 with respective clamping portions oflines 741, 740, 742, 744, 750, 746, 752, and 756. Various suchmechanisms are known in the art such as supports that hold tubingportions at predefined positions in cassettes and cartridges and compactfluid circuits that can be easily laid over a set of actuators andsensors. The manifolds and clamps can be replaced by a variety ofdifferent types of flow selector devices known in the art, so thecurrent proportioning and treatment system is not limited to using flowselectors based on clamping of tubing. If the pump 762 is a peristalticpump, a pumping tube segment of line 763 may be aligned by theconnection of the fluid circuit 701F. The purified water source 766 maybe housed in an enclosure 767 together with the drain line circuit 765or portions of either. The waste container 768 may be housed in the sameenclosure, or not, as illustrated. The concentrate containers 736 and738 may contain sufficient concentrate for multiple fill/drain cycles,multiple days' worth of treatments, each consisting of multiplefill/drain cycles, a week's worth of treatments, a month's worth oftreatments, or some other schedule. The concentrate containers 736 and738 may be independently replaceable by use of the aseptic connectors.The benefits of independent replacement are discussed elsewhere in thepresent disclosure. The contents of the last fill medicament container734 may be fully diluted or may consist of, or include, a concentratethat requires further dilution. The manifolds 758 and 760 may have aminimum volume to reduce waste when changing over fluids. Inembodiments, the maximum hydraulic diameters of the manifolds 758 and760 are each no more than 5 times the diameter of the largest lineconnecting to them. In further embodiments, they are no more than 3times the diameter of the largest line and in still further embodiments,no more than twice. In other respects, the embodiment of FIG. 23 isidentical to that of FIG. 18A.

FIG. 17C shows an proportioning and treatment system for peritonealdialysis 700C. Two multi-treatment containers 736 and 738 containelectrolyte concentrates and osmotic agent concentrates, respectively.They are connected by aseptic connectors 730 to a fluid circuit 701C byrespective osmotic agent concentrate 744 and electrolyte concentrate 742lines. Non-aseptic connectors may also be used. In embodiments, wherethe connectors are non-aseptic, the osmotic agent concentrate 744 andelectrolyte concentrate 742 lines contain sterilizing filters. Due tothe cost and number of filters required this is not a preferred way toensure sterility. A last fill container 734 may also be connected to thefluid circuit 701C via last fill line 740. The last fill container 734may contain a specific medicament for the last fill cycle of amulti-cycle treatment. The fluid circuit 701E contains first 758 andsecond 760 manifolds connected by a pumping tube 763. The manifolds 758and 760 define selectable fluid paths connecting various sources offluids to fluid consumers using clamps 751 under control of a controller739. The details of the flow switching may be as discussed above withrespect to similar embodiments. A purified water source 766 suppliespurified water to the manifold 758 through redundant sterilizing filtersas shown FIG. 17A at 731, or a testable filter may be used as shown inFIG. 17C. The filter 733 is a single testable filter that isautomatically tested by pumping air by means of an air pump through anair line 737 and measuring pressure, detecting whether the filter'sbubble point has been exceeded, and if not, confirming the integrity ofa filter membrane of the filter 733. Alternative filter integrity testsmay also be provided such as a pressure decay test. The test of thefilter 733 is used by the controller 739 to confirm that a batch issterile as described in method embodiments in the present disclosureManifold 760 is connected by a drain line 756 to a conductivity sensormodule 714 through a non-aseptic connector 729. The conductivity sensormodule 714 is a replaceable component interconnectable between outletmanifold 760 and a waste container 768 (or a waste outlet such as adrain). The conductivity sensor module 714 has a pair of conductivitysensors 764 in a drain channel 715. The conductivity sensors 764 provideindependent indications of conductivity that can be compared to indicatea bad sensor and/or to provide a mechanism for flow sensing based on atime of flight of a conductivity perturbation in the flow through thedrain channel 715. The conductivity module 714 engages with theproportioning/cycler machine 772 which houses a valve actuator 721. Thelatter is not replaced when the conductivity module 714 is replaced. Theconductivity module 714 can be a low-cost component by employing plasticconductivity cells, a tube with connectors and a pinching portiondefining a valve 751 by separating the valve actuator 721 (the one shownthat controls flow through the drain channel 715) from the tube pinchingportion and employing injection-molded rigid plastic for theconductivity cells 764, tubing to define the drain channel 715, asepticconnectors 729 such as locking luer-type, and a housing or supportindicated at 714.

A mixing container 732 is connected by inlet and outlet lines 746 and750 to the manifolds 758 and 760, respectively, to allow fluid to bepumped into the mixing container 732, to be drawn from the mixingcontainer 732, and to permit mixing via recirculation of the contents ofthe mixing container 732. A pump 762 pumps fluid between the manifolds758 and 760. A waste container 768 may be attachable to the drain linecircuit 756 by a non-aseptic connector 729. A heater 770 contacts themixing container 732. In embodiments, the heater 770 forms a bed onwhich the mixing container 732 rests.

A patient line 754 is connected to the fluid circuit in such a manner asto ensure that fluid sent to the patient through fill line 755 issterile filtered by sterilizing filter 719, thereby providing a sole, oradditional, assurance against exposure of the patient to unsterile fluidincluding fluids or fluids containing pyrogens, which, as is known, maybe removed by filter membranes with a suitably small pore diameter, forexample, 0.2 micron.

A patient fill/drain line 754 has an air detector 753. Fluid is receivedthrough a junction from a fill line 755 and drained through drain line748, flow being controlled in each of the fill line 755 and the drainline 748 by respective valves 751. Fluid is supplied to a batch inletline 746 and the fill line 755 from header 760 through a commonbatch/fill line 716 from a respective junction 717. The selection of thetwo branches of the junction, namely the batch inlet line 746 and thefill line 752 is carried out by respective valves 751 that control flowthrough these branches. A sterile/pyrogen filter 733 filters all fluidflowing to the patient by filtering all fluid flowing through the fillline 752. This may obviate the need for any other filters on fluidentering the system such as water inlet 741 using filter 733 on thepatient fill line. A common fill/inlet line 716 feeds the inlet 746 andfill 755 lines. The line 755 which conveys fluid to the patient 718 hasa testable sterile filter 719. Flow through lines 746 and 755 iscontrolled by respective valves 751.

The controller 739 may invoke a failsafe operation if air is detectedabove a predefined threshold in the fill drain/line 754. Flow in inletline 746 is controlled with the additional function that the valve 751controlling flow in the fill line 755 is closed when fluid is directedto the mixing container 732.

The fluid circuit 701C connects to proportioning/cycler machine 772 by amechanism that align clamps 751 with respective clamping portions oflines 741, 740, 742, 744, 750, 746, 752, 755, and 756. Various suchmechanisms are known in the art such as supports that hold tubingportions at predefined positions in cassettes and cartridges and compactfluid circuits that can be easily laid over a set of actuators andsensors. The manifolds and clamps can be replaced by a variety ofdifferent types of flow selector device known in the art, so the currentproportioning and treatment system is not limited to using flowselectors based on clamping of tubing. If the pump 762 is a peristalticpump, a pumping tube segment of line 763 may be aligned by theconnection of the fluid circuit 701C. The purified water source 766 maybe housed in an enclosure 767 together with the drain line circuit 765or portions of either. The waste container 768 may be housed in the sameenclosure, or not, as illustrated. The concentrate containers 736 and738 may contain sufficient concentrate for multiple fill/drain cycles,multiple days' worth of treatments, each consisting of multiplefill/drain cycles, a week's worth of treatments, a month's worth oftreatments, or some other schedule. The concentrate containers 736 and738 may be independently replaceable by use of the aseptic connectors.The benefits of independent replacement are discussed elsewhere in thepresent disclosure. The contents of the last fill medicament container734 may be fully diluted or may consist of, or include, a concentratethat requires further dilution. The manifolds 758 and 760 may have aminimum volume to reduce waste when changing over fluids. Inembodiments, the maximum hydraulic diameters of the manifolds 758 and760 are each no more than 5 times the diameter of the largest lineconnecting to them. In further embodiments, they are no more than 3times the diameter of the largest line and in still further embodiments,no more than twice. Pressure sensors 769 are positioned on either sideof the pump 762 to detect pump inlet and outlet pressures in pump tube763. Signals corresponding to the pressures are applied to thecontroller 739 and used for pump pressure compensation and/or pumpcalibration as discussed elsewhere and in US Patent Publication2015-0005699, hereby incorporated by reference in its entirety herein.

FIG. 17D shows an proportioning and treatment system for peritonealdialysis 700D with a fluid circuit 701D. The system 700D differs from700C in that a testable sterilizing filter 719 is used for the fill line755 to ensure against infusion of pyrogens and/or pathogens.

Note that instead of separate inlet 746 and outlet 750 lines leadinginto and out of the mixing container 732, the mixing container 732 maybe attached by a single line. In such a case, mixing of the contents maybe accomplished by flowing fluid between the mixing container 732 and anaccumulator connected to one of the manifolds. A flow switch could beused to interconnect the single line of the mixing container to aselectable one of the manifolds. Also, the pump 762 may be run in eitherdirection so that the inlet and outlet lines 746 and 750 can switchroles under control of the controller. Thus, the modifiers “inlet” and“outlet” serve to differentiate the two lines 746 and 750 but are notstrictly limiting in terms of structure or function and it should beevident that the functionality of batch preparation, mixing, andtreatment can be carried out with the roles of inlet and outlet switchedduring certain operations. For other operations, the manifolds may bemodified to permit a different fluid source and destination to beselected that is not possible with the depicted configuration. Suchvariations are contemplated within the scope of the disclosure unlessotherwise expressly limited.

FIG. 18A shows a fluid circuit 701E having a disposable unit that isinitially provided with empty, low-capacity concentrate containers 780and 781 which are filled from multi-treatment concentrate containers 736and 738 during a dialysis fluid preparation cycle. A proportioning andtreatment system for peritoneal dialysis 700E has two multi-treatmentconcentrate containers 736 and 738 that contain electrolyte concentratesand osmotic agent concentrates, respectively. The multi-treatmentconcentrate containers 736 and 738 are connected through a fluid module723 by means of a single fluid intake line 728 which has a testablefilter 733 that forms part of a disposable with a fluid circuit 701E.The disposable unit is connected through the fluid intake line 728 by anaseptic connector 743 (same type as 729) to the fluid module 723. Thefluid module 723 may be a permanent structure that receivesmulti-treatment concentrate containers 736 and 738 as a replaceable unitor as separate containers according to various embodiments. The fluidmodule 723 may also have a pump 788 and a purified water source 766 aswell as a fluid switch circuit 747 that provides for the selective flowof water and the different concentrates into the fluid intake line 728.

The testable filter 733 may be preconnected to the fluid circuit 701Eand sterilized with the remainder of the fluid circuit 701E as a unitwhich may be sealed in a sterile package and delivered for use. An airpump 735 and pressure sensor 727 may be provided as a permanent fixtureof the proportioning/cycler machine 772.

The initially empty low-capacity concentrate containers 780 and 781 arepreconnected along with the initially empty mixing container 732 to theremainder of the fluid circuit 701E. The low-capacity concentratecontainers 780 and 781 may be filled, as discussed later, with osmoticagent concentrate and electrolyte concentrate from multi-treatmentconcentrate containers 736 and 738, respectively. A last fill container734 may also be connected by an aseptic connector 730 to the fluidcircuit 701E via last fill line 740. The last fill container 734 maycontain a specific medicament for the last fill cycle of a multi-cycletreatment. The contents of the last fill medicament container 734 may befully diluted or may consist of, or include, a concentrate that requiresfurther dilution.

The fluid circuit 701E contains first 758 and second 760 manifoldsconnected by a pumping tube 763. The manifolds 758 and 760 defineselectable fluid paths connecting various sources of fluids to fluidconsumers using clamps 751 under control of a controller 739. Thedetails of the flow switching may be as discussed above with respect tosimilar embodiments. The manifolds 758 and 760 may have a minimum volumeto reduce waste when changing over fluids. In embodiments, the maximumhydraulic diameters of the manifolds 758 and 760 are each no more than 5times the diameter of the largest line connecting to them. In furtherembodiments, they are no more than 3 times the diameter of the largestline and in still further embodiments, no more than twice. Pressuresensors 769 are positioned on either side of the pump 762 to detect pumpinlet and outlet pressures in pump tube 763. Signals corresponding tothe pressures are applied to the controller 739 and used for pumppressure compensation and/or pump calibration as discussed elsewhere andin US Patent Publication 2015-0005699, hereby incorporated by referencein its entirety herein. A waste container 768 may be attachable to thedrain line circuit 765 by a non-aseptic connector 729.

The filter 733 is a single testable filter that is automatically testedby pumping air by means of an air pump 735 through an air line 737 andmeasuring pressure by means of pressure sensor 727, detecting whetherthe filter's bubble point has been exceeded, and if not, confirming theintegrity of a filter membrane of the filter 733. Alternative filterintegrity tests may also be provided such as a pressure decay test. Thetest of the filter 733 is used by the controller 739 to confirm that abatch is sterile as described in method embodiments in the presentdisclosure.

Manifold 760 is connected by a drain line 756 to a conductivity sensormodule 714 through a non-aseptic connector 729. The conductivity sensormodule 714 is a replaceable component interconnectable between theoutlet manifold 760 and a waste container 768 (or a waste outlet such asa drain). The conductivity sensor module 714 has a pair of conductivitysensors 764 in a drain channel 715. The conductivity sensors 764 provideindependent indications of conductivity that can be compared to indicatea bad sensor and/or to provide a mechanism for flow sensing based on atime of flight of a conductivity perturbation in the flow through thedrain channel 715. The conductivity module 714 engages with theproportioning/cycler machine 772 which houses a valve actuator 721. Thelatter is not replaced when the conductivity module 714 is replaced. Theconductivity module 714 can be a low-cost component by employing plasticconductivity cells, a tube with connectors and a pinching portiondefining a valve 751 by separating the valve actuator 721 (the one shownthat controls flow through the drain channel 715) from the tube pinchingportion and selecting a low cost arrangement for the conductivity cells764, the tubing forming the drain channel 715, the connectors 729, and ahousing or support indicated at 714.

A mixing container 732 is connected by inlet and outlet lines 746 and750 to the manifolds 758 and 760, respectively, to allow fluid to bepumped into the mixing container 732, to be drawn from the mixingcontainer 732, and to permit mixing via recirculation of the contents ofthe mixing container 732. A pump 762 pumps fluid between the manifolds758 and 760. A waste container 768 may be attachable to the drain linecircuit 765 by a non-aseptic connector 729. A heater 770 contacts themixing container 732. In embodiments, the heater 770 has a bed on whichthe mixing container 732, in the form of a plastic bag, rests. A patientline 754 is connected by a Y-connector to separate lines 748 and 752 topermit the filling and draining of a patient 718 through the patientline 754, which is connected to a catheter (not shown) by means ofanother aseptic connector 730. A sample line 757 is connected to asample container 773 through a non-aseptic connector 729, or may bepre-attached. A valve 751 controlling flow through the sample line 757is controlled to sample fluid from the header 760 automatically by thecontroller 739. In embodiments, a temperature of draining dialysis fluidis monitored for a condition indicating an infection or some othercondition for which a sample may be automatically drawn and storedduring draining according to the condition. See US 2015-0005699,incorporated by reference elsewhere herein and International patentpublication WO2018045102, hereby incorporated by reference in itsentirety for details of how parameter monitoring of the spent dialysisfluid may be used to detect a condition.

The fluid circuit 701E connects to proportioning/cycler machine 772 by amechanism that align clamps 751 with respective clamping portions oflines 741, 740, 742, 744, 750, 746, 752, and 756. Various suchmechanisms are known in the art such as supports that hold tubingportions at predefined positions in cassettes and cartridges and compactfluid circuits that can be easily laid over a set of actuators andsensors. The manifolds and clamps can be replaced by a variety ofdifferent types of flow selector devices known in the art, so thecurrent proportioning and treatment system is not limited to using flowselectors based on clamping of tubing. If the pump 762 is a peristalticpump, a pumping tube segment of line 763 may be aligned by theconnection of the fluid circuit 701B.

The concentrate containers 736 and 738 may contain sufficientconcentrate for multiple fill/drain cycles, multiple days' worth oftreatments, each treatment consisting of multiple fill/drain cycles. Forexample, concentrate containers 736 and 738 may contain sufficientconcentrate a week's worth of treatments, a month's worth of treatments,or some other schedule. The concentrate containers 736 and 738 may beindependently replaceable by use of the aseptic connectors. The benefitsof independent replacement are discussed elsewhere in the presentdisclosure. The pump 788 draws and pumps a concentrate selected byvalves that control flow through electrolyte concentrate line 790 andosmotic agent concentrate line 789, respectively. The output of the pump788 is pumped through a common concentrate line 791 through theconnector 743 into the fluid intake line 728. When water is conveyedthrough the fluid intake line, it is pumped by the pump 762 withcorresponding valves opened as in prior embodiments by closing thevalves 751 that control flow through electrolyte concentrate line 790and osmotic agent concentrate line 789, respectively, and by opening thevalve 751 that controls the flow through a water source line 792. Apressure sensor 727 may be provided in the water source line 792 tocontrol the flow of water as described with reference to FIGS. 19Athrough 19M.

Note that in all the embodiments having a water source such as 766, thelatter may be provided with a pump 794 that pumps water independently ofthe pump of a downstream proportioning device and/or cycler such as pump762.

FIGS. 18B through 18D are a single flow chart illustrating a methodembodiment for controlling the embodiment of FIG. 18A. The chart portionof FIG. 18B is linked at the end to the beginning of the flow chart ofFIG. 18C as indicated by the letter A in a circle. The chart portion ofFIG. 18C is linked at the end to the beginning of the flow chart of FIG.18D as indicated by the letter B in a circle. At S502, the pump 762 isused to pump water from the fluid source module 723 to the drain toprime the fluid circuit manifolds 758 and 760 as well as the linesleading from the fluid source module 723 to the waste container or drain768. The controller 739 stores a predefined value to indicate how muchwater to pump at this stage. For example, the controller 739 may store apredefined number of cycles of the pump 762 or a predefined volume. Thecontroller 739 may be programmed to translate the predefined volume to apredefined number of cycles to implement a control procedure to regulatethe volume transferred responsively to the predefined volume.Alternatively, the controller 739 may store a predetermined speed andinterval of operation that corresponds to the predefined volume. Otheralternatives are possible. In the operation S502, only the valves 751required to open the specified path are opened and the others are closedto restrict flow to the predefined path. This is the case for all theoperations described by the flow chart.

At S503, an optional operation is performed in which a sample of eachconcentrate is pumped to the drain to generate a pressure drop acrossthe filter 733 and to use the pressure drop to identify the type ofconcentrate solution by its viscosity. For example, the osmotic agentconcentrate is more viscous than the electrolyte concentrate, andtherefore the pressure drop for a given flow rate will be higher. Thepressure drop may be indicated by a single downstream pressure by thepressure sensor 769 since the upstream pressure may be assumed to besufficiently identical between the two test conditions to indicate adifference. Thus, a lower pressure at sensor 769 would indicate the moreviscous fluid. The controller 739 may store the identity of the type ofconcentrate associated with lines 789 and 790 and control thecorresponding valves 751 accordingly. Alternatively, if one type ofconcentrate is required to be connected to a respective connector, thenthe controller 739 may identify a misconnection and generate an outputfrom the controller indicating the misconnection so that correctiveaction can be taken.

At S504, the valves 751 are opened to define a path from the watersource 766 to the waste container or drain 768. Water is pumped by thepump 794 in tandem with the pump 762 to flush the path with water.Optionally, the conductivity of the fluid passing by conductivitysensors 764 may be detected to serve as an indication that sufficientwater has been flushed to prime and clear the flow path. Alternatively,another criterion may be used to stop the flow of water, such as apredetermined volume of water being flushed.

At S505, a quantity of electrolyte concentrate sufficient to prime thelines from the electrolyte concentrate container 736 through themanifold 758 and at least partly into the outflow line 750 is pumped bypump 788. This process may prime the sterilizing filter 733. The totalquantity may be selected to be sufficient to ensure that the sterilizingfilter 733 is primed and flushed of any air. This priming step may beperformed at a preselected flow rate determined to be optimal forpriming of the filter 733, for example a flow rate of about 30 ml/min.

At S506, a sufficient quantity of electrolyte concentrate for a singlecycle or for a full treatment (e.g., daily treatment) including multiplefill cycles is pumped through the path 790, 791, 728, 745, 758, 742 withall valves 751 closed except those defining this path. This has theeffect of priming the electrolyte concentrate line 742 as well asproviding a sufficient amount of electrolyte concentrate in the osmoticagent container 781 to generate multiple batches each for respectivefill cycles in sufficient number for a full treatment, for example asingle day's treatment.

At S510, the pump 788 pumps sufficient osmotic agent concentrate intomixing container 732 to prime the lines and the header 760. The linesinclude batch outlet line 750, fluid line 745, and osmotic agentconcentrate line 789, which are opened by means of respective valves751. The volume transferred may be determined to be sufficient to primethe lines and header 760 leading to osmotic agent concentrate line 744.

At S514, a sufficient quantity of osmotic agent concentrate for a singlecycle or for a full treatment (e.g., daily treatment) that includesmultiple fill cycles, is pumped through the path 790, 791, 728, 745,758, 744 with all valves 751 closed except those defining this path.This has the effect of priming the osmotic agent concentrate line 742 aswell as providing a sufficient amount of osmotic agent concentrate inthe osmotic agent container 781 to generate multiple batches each for arespective fill cycle and in sufficient number for a full treatment, forexample a single day's treatment.

At S520, a flow channel is established by closing all valves 751 exceptones required to flow from the water source 766 to outlet line 750.Water is pumped from the water source 766 using the pump 794 to primethe manifold 758 and the outlet line 750 thereby transferring a smallamount of water into the mixing container 732.

At S522, a recirculating channel between in the inflow 746 and outflow750 lines through the pump 762 is established and the mixing container732 contents are pumped for a period of time or a number of pumprotations sufficient to break in the pumping tube segment of pump tube763. The contents of the mixing container 732 may be mixed by thisprocess.

At S528, if a special last fill, different from the prescriptionsgenerated from the concentrates, is to be used, a special last fillmedicament container 734 will be provided. At S528, the last fill line740 may be primed by flowing a portion of the last fill container 734contents to a waste container or drain 768 to prime the last fill line740.

At S30, the pump 794 pumps a pre-determined volume of water into themixing container 732. The pump recirculates fluid from the mixingcontainer 732 through inflow and outflow lines 746 and 750 for a timesufficient to break in pump tube segment and mix contents. This is aclosed loop path that includes the manifolds 758 and 760, the inflow andoutflow lines 746 and 750 and the mixing container 732.

At S532, the controller 739 performs an integrity test of the filter 733on fluid intake line 728. This is to confirm that all fluids that haveflowed into the fluid circuit are sterile/pyrogen-free. If the integrityof the filter membrane is not confirmed, the controller 739 may performan error recovery operation by instructing the operator to replace fluidcircuit 701E. The controller 739 is programmed at least to generate asignal indicating a failed test. The controller 739 may prevent fluid inthe mixing container 732 from being used by pumping the contents to thedrain automatically and generating an output on the user interfaceindicating a failed filter, along with instructions for replacing thefluid circuit.

A S534, the controller 739 opens a circuit through manifolds 758 and 760from the water source to drain and flows water through the open circuitto rinse the conductivity sensors 764. The conductivity may be monitoredby the controller 739 to confirm that a sufficient amount of water hasbeen transferred to rinse the conductivity cells to a predeterminedthreshold.

At S536, the controller 739 opens a circuit including line 742 throughmanifolds 758 and 760 through to drain and passes a small bolus (e.g.,6-8 ml) from electrolyte concentrate container 780 into manifold 758.This stores a marker in the line that ultimately gets pumped to theconductivity sensors 764 and is used for calibration of the pump 762.

At S538, a circuit is opened by operating valves 751 that includes waterline 728 manifolds 758 and 760 and runs through to the drain from thepurified water source 766 to flow a small purified water spacer (e.g. 10ml.) from the fluid module 723 into the open circuit such that it flowsinto it but does not reach the conductivity sensors nor does it push thebolus formed at S536 to the conductivity sensors. Rather, the bolus andthe spacer are queued in the fluid path waiting for S540 to perform acalibration operation by measuring time of flight of the bolus. That is,with a fixed volume of the channel between the conductivity sensors, thesystem can be calibrated to determine the flow rate from the time delaybetween the indications of the perturbation crossing the twoconductivity sensors.

At S540, the controller 739 opens a circuit including outflow line 750through manifolds 758 and 760 through to drain and pumps sufficientfluid from mixing container 732 (about 50 ml) to push the electrolyteconcentrate bolus and the water spacer past the conductivity sensors 764to calibrate the pump. This system is described in the US 2015-0005699incorporated by reference. The technique is for the controller tocalculate the volume flow rate of fluid by detecting the cross of aconductivity perturbation across two spaced apart conductivity sensors.With a fixed volume of the channel between the conductivity sensors, thesystem can be calibrated to determine the flow rate from the time delaybetween the indications of the perturbation crossing the twoconductivity sensors.

At S542, the controller 739 flows sufficient water toward mixingcontainer 732 (about 22.6 ml. for example) to fill inflow line 746 withwater. To ensure the inflow line 746 is completely filled, an amountsufficient to transfer some water to the mixing container 732 is pumped.

At S544 the controller 739 runs the pump 762 so as to drain the mixingcontainer 732 until a vacuum is detected on pressure sensor 769. Thecontroller then calculates a discounted value for fluid accountingpurposes accounting for the total volume of water MOTI in 746 to accountfor effect of vacuum drawn on the inflow line 746

At S546 the controller 739 pumps water to the drain to prime themanifolds 758 and 760 with water. All valves 751 are closed except thosethat define a path from the water source 766 to the drain.

At S548 the controller 739 pumps 100% or less (e.g. 50%) of a targetvolume of water into the mixing container 732. This is the amount ofwater the controller 739 determines is required for a ready-to-use PDdialysis fluid according to a current prescription stored by thecontroller 739.

At S550 the controller 739 pumps a predetermined amount of water frommixing container 732 to waste container or drain 768 to fill the mixingcontainer 732 outflow line 750 with water to fill the volumes defined asMIMO, MOTI, and SOMI, that is, the inflow and outflow lines 746 and 750,the manifolds 758 and 760 and the pump tube 763.

At S552 the controller 739 pumps 100% of the electrolyte concentraterequired for the target prescription into the mixing container 732(noting that the reverse order of electrolyte and osmotic agent is alsopossible, so osmotic agent with electrolyte sufficient to act as amarker may be added first instead).

At S554 the controller 739 mixes the mixing container 732 contents byrecirculating through the lines 746 and 750 and the manifolds 758 and760 using the pump 762.

At S556 the controller 739 opens a path from the mixing container 732 tothe drain and pumps a quantity of its contents sufficient to testconductivity to confirm the level of dilution of electrolyte. Anydifference between the actual and expected conductivity measurements iscompared to a threshold and if the threshold is exceeded, at S558,additional water or electrolyte concentrate may be added to provide thetarget ratio.

At S558 the controller 739 conditionally pumps further water orelectrolyte concentrate responsively to the previous conductivity testdone at S556. This process may be iterative to provide, effectively, atitration until the required ratio of electrolyte to water is achieved.In embodiments, the total measured water volume is used as ground truthby the controller 739 for purposes of adjusting the second concentrate(osmotic agent concentrate in this example) to be added.

At S560 the controller 739 pumps osmotic agent concentrate into themixing container 732 using ratiometric control of transferredconcentrate (noting the reverse order of concentrates is also possible).

At S562, the controller 739 mixes the mixing container 732 contents byrecirculating through the lines 746 and 750 and the manifolds 758 and760 using the pump 762.

At S564 the controller 739 tests conductivity of mixing containercontents and passes or fails the batch based on the result by passing asample from the mixing container 732 to the conductivity sensors 764.

At S566, the controller 739 determines and adds the complement of waterdepending on the initial amount provided at S548. In the example of 50%water, the 50% balance of water is added. If the quantity of water wasadjusted in S558, then the balance is adjusted based on any additionalquantity added to the contents of the mixing container 732.

At S568, the mixing container contents are mixed by the controller 739by recirculating through the lines 746 and 750 and the manifolds 758 and760 using the pump 762.

At S570, the controller 739 tests conductivity of mixing container 732contents and passes or fails the batch based on the result. At thispoint, the failure of the batch may not be compensated by adjusting itsconstituents. If the contents do not meet the predefined expectedconductivity, the contents of the mixing container 732 may be blockedfrom further use and a signal may be generated to indicate the failure.In embodiments, the contents of the mixing container 732 may beautomatically flushed to drain in the event of a failure.

At S572, the controller 739 tests the sterilizing filter(s) and passesor fails the completed batch based on the result of the filter test. Atthis point, the contents of the mixing container 732 may be blocked fromfurther use and a signal may be generated to indicate the failure. Inembodiments, the contents of the mixing container 732 may beautomatically flushed to drain in the event of a failure.

FIGS. 18E through 18H show various fluid circuit configurations for thefluid module 723 of the foregoing embodiments such as that of FIG. 18A.In the embodiment of FIG. 18E, a fluid module 723A has concentratecontainers 736 and 738 which are preconnected to the respectiveconcentrate lines 790 and 789 which are interconnected to a connector798 for connection to the water inlet of a fluid circuit such as that ofFIG. 18A. In this embodiment, the concentrate containers 736 and 738 maybe mechanically attached to each other or enclosed in a common housingindicated at 795A to form a single unit that may be replaced, as a unit,when one of the concentrate containers, 736 or 738, is exhausted. FIG.18F shows an embodiment in which the concentrate containers 736 and 738each has its own connector 799 which allows each of the concentratecontainers 736 and 738 to be replaced independently of the other. Theconcentrate containers 736 and 738 may be housed, or held, in apermanent fixture 795B. FIG. 18G shows a fluid module 723C where one ofthe concentrate containers 738 is not disconnectable from a fluid line(here, osmotic agent concentrate line 789) while the other concentratecontainer 736 is connected by a removable connector 799. In embodiments,which of the two concentrates is not disconnectable can be reversed sothat the electrolyte concentrate container 736 is not disconnectable andthe osmotic agent concentrate container 738 is disconnectable. In thisembodiment, only one of the types of concentrate is ever preconnected toa line, such as line 789. The configuration of the embodiment of FIG.18G prevents connection of a respective one of the lines 789 and 790 tothe wrong type of concentrate container. FIG. 18H shows an embodiment723D in which separate testable filters are provided for each of theconcentrates 736 and 738. In this case, the fluid module may have itsown air pumps 735 and pressure sensors 727.

Note that in any of the embodiments, the air pump's 735 functions may beprovided by a single pump with multiple lines stemming from a commonoutput. Each may be controlled by a respective valve under control ofthe controller.

Note that in any of the embodiments in which a fluid source module isprovided to actively pump fluid to a consuming appliance such asproportioning and treatment systems for peritoneal dialysis 700A-700E,the fluid module may be controlled by direct electronic communicationsuch as wired or wireless. Such direct communication may be used forclosed loop control of the fluid module pump by the proportioning andtreatment system for peritoneal dialysis controller, for example.

In any of the fluid module embodiments (723, 723A, 723B, 723C, 723D),the pump 794 that pumps water may be of a type that pushes water througha filtration system and may be of a high precision non-pulsatile typesuch as a gear pump or a screw pump. This pump, indicated in embodimentsat 794, may be closed-loop controlled based on pressure by the pressuresensor 727A. In any of the fluid module embodiments, the valve of thetype 751 indicated at 749 in FIG. 18A and corresponding locations inother embodiments is controlled by the controller 739.

In embodiments in which the water pump 794 is activated and deactivatedin response to pressure (see for example FIGS. 9A-19C and associateddiscussion) and is also closed-loop controlled to maintain a predefinedpressure range, the control of the water pump 794 may be regulated by acontrol algorithm such that a pressure rise above a predefined level orabove a predefined rate due to the halting of the cycler pump may bedetected quickly. For example, if the pressure rises above a predefinedlevel or rises faster than a predefined rate, the water pump controllermay detect that condition and halt the water pump rather than slewing toa low flow rate in response to the close-loop control algorithm. Thecontroller may also terminate closed-loop control of the flow rate ifsuch a condition is detected.

The direct control of water and/or other fluid sources by wired orwireless digital signals may be preferred. FIGS. 19A-19H and 19J-19Mshow embodiments for control of a fluid source, here exemplified by awater source 810, without direct data communications applying controlinputs from a medical treatment device, here exemplified by a peritonealdialysis fluid preparation device 800, which may optionally have acycler as well. Referring to FIG. 19A, a peritoneal dialysis fluidpreparation device 800 has a pump 808 and a fluid circuit 802 for mixingfluids and for performing a peritoneal dialysis treatment. The watersource 810 has a pump 806 that conveys water to the peritoneal dialysisfluid preparation device 800 through a water line 803. A pressure sensor804 detects pressure in the water line and applies a correspondingsignal to a controller 807 of the water source 810. The controller 807controls the pump 806. FIG. 19B shows a control loop executed by acontroller 809 of the peritoneal dialysis fluid preparation device 800.At S400, the controller 809 receives or generates a command for water.This may be as described in the foregoing embodiments as incident to aconcentrate dilution operation in the preparation of a dialysis fluid bythe peritoneal dialysis fluid preparation device 800. At S402A theperitoneal dialysis fluid preparation device 800 begins operating thepump 806 to draw water through the water line 803. At S412, theperitoneal dialysis fluid preparation device 800 pump 806 draws aquantity of water until a command is received or generated at S414 tohalt the pumping of water whereupon at S416A, the pump 806 isdeactivated. FIG. 19C shows a control loop executed by the controller807. At S404A, the water source 810 controller detects a pressure belowa predetermined threshold indicated by the pressure sensor 804. A dropin pressure is caused by the S402A operation which causes a negativepressure in the water line 803. Note that instead of an absolute (gaugeor absolute pressure in absolute terms) pressure, the controller 807 atS404A may respond to a predefined rate of change of pressure or apredefined total pressure change over a predefined interval of time. Thepredefined ranges may be stored in a memory of the controller 807. S404Aloops continuously until the condition is met. At S405A, the controller807 activates the water pump 806 causing water to flow into the waterline and alleviating the negative pressure such that water flows freelyunder control of the pump 808. At S406A, control loops until thepressure indicated by the pressure sensor 804 rises above a threshold orincreases a predefined total amount or at a predefined rate whereuponthe water source pump 806 is halted at S409. The rise in pressure iscaused by the operation S414. Thus, the water source 810 isautomatically demand-controlled by the peritoneal dialysis fluidpreparation device 800 controller 809 without a signal connectionbetween the controllers 809 and the water source 810 controller 807.

Although the embodiments described with reference to FIGS. 19A through19M described the peritoneal dialysis fluid preparation device 800 ascontrolling the halting of the water source 810 pump 806, it is possiblein variations of these embodiments to instead cause the halting of thewater source 810 pump to be controlled by providing the controller 807with a predefined volume of water or a predefined pumping time. Waterpump 806 will halt automatically after being started so that theperitoneal dialysis fluid preparation device 800 can halt operation ofpump 808 independently.

Thus, in operation, the peritoneal dialysis fluid preparation device 800controller 809 start the water source 810 pump 806 as described in theembodiments 19A through 19M, but the halting of the pump occursautomatically as a result of the expiration of the predefined volume orrunning time.

Note also, that in the embodiment of FIGS. 19G, 19H, and 19J thecontroller 809 may transmit, by means of pressure pulse signals, theduration of pumping by the water pump 806 or the amount to be pumped, bythe peritoneal dialysis fluid preparation device 800 controller 809 tothe water source 810 controller. This may allow the peritoneal dialysisfluid preparation device 800 controller 809 to establish the volume offluid or the duration of pumping.

In any of the embodiments, the pressure modulator may generate pulses bymodulating the peritoneal dialysis fluid preparation device 800 pump808. For example, such pumps may be driven by motors that allow forwardand reverse movement such as by means of a stepper motor drive. Othermeans for creating pulses are also possible such as an independentactuator such as a solenoid-driven diaphragm pump. Further variationsare described elsewhere in the present application.

Note also in the embodiment of FIGS. 19A-19C, in alternativeembodiments, the water source 810 may halt the flow of water after acertain quantity of water has been pumped by pump 806, instead ofreceiving a command at S414. In other embodiments, the pump 808 maygenerate a pressure spike when it is halted by the controller 809. Thisspike may be detected by the pressure sensor 804 and cause thecontroller 807 to halt the pump 806.

Referring now to FIG. 19D, as in the embodiment of FIG. 19A, theperitoneal dialysis fluid preparation device 800 has a pump 808 and afluid circuit 802 for mixing fluids and for performing a peritonealdialysis treatment. The water source 810 has a pump 806 that conveyswater to the peritoneal dialysis fluid preparation device 800 through awater line 803. The controller 807 controls the pump 806. A power supply815 provides power to the pump 808. In the water source, a voltagedetector 816 is connected to the power supply 815 or power leads leadingto the pump 808, to detect power sent to the pump 808. Thus, the voltagedetector 816 applies a signal to the controller 807 indicating when thepump 808 is activated. The pressure sensor 804 may be used for flowcontrol of the pump 806 to ensure the tandem operation of the pumps 808and 806 are synchronized by flow such that the pump 806 does not undulyresist the pumping of pump 808. A closed loop control of pump 806,executed by controller 807, on a pressure set point may accomplish this.This closed loop control may be provided in embodiments. FIG. 19E showsa control loop executed by a controller 809 of the peritoneal dialysisfluid preparation device 800. At S400, the controller 809 receives orgenerates a command for water. This may be as described in the foregoingembodiments as incident to a concentrate dilution operation in thepreparation of a dialysis fluid by the peritoneal dialysis fluidpreparation device 800. At S402A the peritoneal dialysis fluidpreparation device 800 begins operating the pump 806 to draw waterthrough the water line 803. At S412, the peritoneal dialysis fluidpreparation device 800 pump 806 draws a quantity of water until acommand is received or generated at S414 to halt the pumping of waterwhereupon at S416A, the pump 806 is deactivated. FIG. 19F shows acontrol loop executed by the controller 807. At S404B, the water source810 controller detects a voltage above a predetermined thresholdindicated by the voltage detector 816. The predefined threshold may bestored in a memory of the controller 807. S404B loops continuously untilthe condition is met. At S405B, the controller 807 activates the waterpump 806 causing water to flow into the water line and alleviating thenegative pressure such that water flows freely under control of the pump808. At S406B, control loops until the voltage indicated by the voltagedetector 816 falls below a predefined threshold which may be differentfrom the one at S404B, whereupon the water source pump 806 is halted atS409. The fall in voltage is caused by the operation S414. Thus, thewater source 810 is automatically demand-controlled by the peritonealdialysis fluid preparation device 800 controller 809 without a signalconnection between the controllers 809 and the water source 810controller 807.

Referring now to FIG. 19G, as in the embodiment of FIG. 19A, theperitoneal dialysis fluid preparation device 800 has a pump 808 and afluid circuit 802 for mixing fluids and for performing a peritonealdialysis treatment. The water source 810 has a pump 806 that conveyswater to the peritoneal dialysis fluid preparation device 800 through awater line 803. The controller 807 controls the pump 806. A pressuremodulator 818 generates pressure pulses in the water line 803 that aredetected by the pressure sensor 804 of the water source 810 to applyresulting pressure pulse indications to a decoder 819 which decodes themto generate command signals that are applied to the controller 807. Thecontroller 809 may store pressure pulse patterns that are thus decodedby the decoder 819. Using pressure pulses, various commands can beencoded and decoded to provide commands to the water source 810 from theperitoneal dialysis fluid preparation device. Such commands may includeto start and stop the pump 806, or to command a speed of the pump 806,for example. The pressure sensor 804 may be used for flow control of thepump 806 to ensure the tandem operation of the pumps 808 and 806 aresynchronized by flow such that the pump 806 does not unduly resist thepumping of pump 808. A closed loop control of pump 806, executed bycontroller 807, on a pressure set point may accomplish this. Thepressure pulse signal generated by the pressure modulator may prescribea pressure setpoint for such closed loop control. The closed loopcontrol may be provided in embodiments. FIG. 19H shows a control loopexecuted by a controller 809 of the peritoneal dialysis fluidpreparation device 800. At S400, the controller 809 receives orgenerates a command for water. This may be as described in the foregoingembodiments as incident to a concentrate dilution operation in thepreparation of a dialysis fluid by the peritoneal dialysis fluidpreparation device 800. At S402B the peritoneal dialysis fluidpreparation device 800 begins operating the pump 806 to draw waterthrough the water line 803 and simultaneously, shortly or immediatelybefore or shortly or immediately afterwards, generates a pulse commandto turn on the water pump 806. At this time, further commands such as apressure setpoint or a speed of the pump 806 may be generated usingpressure pulses through the pressure modulator 818. At S412, theperitoneal dialysis fluid preparation device 800 pump 806 draws aquantity of water until a command is received or generated at S414 tohalt the pumping of water whereupon at S416B, the pump 806 isdeactivated and simultaneously, shortly or immediately before or shortlyor immediately afterwards, generates a pulse command to turn off thewater pump 806. FIG. 19J shows a control loop executed by the controller807. At S404C, the water source 810 controller 807 detects a commandfrom the decoder 819 to start the pump and establish operatingconditions if operating conditions are included in the pulse trainreceived by the decoder 819. S404C loops continuously until thecondition is met. At S405C, the controller 807 activates the water pump806 causing water to flow into the water line and alleviating thenegative pressure such that water flows freely under control of the pump808. The controller 807 may also set operating conditions as indicatedby the received command. At S406C, control loops until a furtherpressure pulse signal command is received by the decoder 819 to halt thepump 806. Thereupon, the water source pump 806 is halted at S409. Thus,the water source 810 is automatically demand-controlled by theperitoneal dialysis fluid preparation device 800 controller 809 withouta wired or radio-based signal connection between the controllers 809 andthe water source 810 controller 807.

Referring now to FIG. 19K, as in the embodiment of FIG. 19A, theperitoneal dialysis fluid preparation device 800 has a pump 808 and afluid circuit 802 for mixing fluids and for performing a peritonealdialysis treatment. The water source 810 has a pump 806 that conveyswater to the peritoneal dialysis fluid preparation device 800 through awater line 803. The controller 807 controls the pump 806. A valveactuator 822 opens and closes a valve 821 that provides for flow intothe fluid circuit 802 from the water line 803. Details of such operationand embodiments are disclosed elsewhere herein. A voltage sensor 816detects the activation of the valve actuator 822 and applies acorresponding signal to the controller 807. Both opening and closingindications may be applied and interpreted by the controller 807 usingknown principles and according to various valve types so details are notdiscussed. The pressure sensor 804 may be used for flow control of thepump 806 to ensure the tandem operation of the pumps 808 and 806 aresynchronized by flow such that the pump 806 does not unduly resist thepumping of pump 808. A closed loop control of pump 806, executed bycontroller 807, on a pressure set point may accomplish this. This closedloop control may be provided in embodiments. FIG. 19L shows a controlloop executed by a controller 809 of the peritoneal dialysis fluidpreparation device 800. At S400, the controller 809 receives orgenerates a command for water. This may be as described in the foregoingembodiments as incident to a concentrate dilution operation in thepreparation of a dialysis fluid by the peritoneal dialysis fluidpreparation device 800. At S402C the peritoneal dialysis fluidpreparation device 800 activates the valve actuator 822 to open thevalve controlling the fluid circuit 802 access to the water line 803 andthen begins operating the pump 806 to draw water through the water line803. At S412, the peritoneal dialysis fluid preparation device 800 pump806 draws a quantity of water until a command is received or generatedat S414 to halt the pumping of water whereupon at S416C, the pump 806 isdeactivated and the valve actuator 822 is activated to close (ordeactivated, depending on the type of valve, for example a solenoidwould be powered-down) the water inlet valve 821. FIG. 19M shows acontrol loop executed by the controller 807. At S404D, the water source810 controller detects a voltage above a predetermined thresholdindicated by the voltage detector 816. This is one example of the directdetection of the opening of a valve. In a linear motor actuated pinchvalve, a forward applied voltage may be detected that runs the linearmotor in a forward direction to close the valve 821 and a reverseapplied voltage may be detected that runs the linear motor in thereverse direction to open the valve 821. For a solenoid valve, apredefined threshold voltage may be stored in a memory of the controller807 to indicate the valve open position of the actuator 822. For othertypes of actuator, a suitable mechanism for direct detection of thevalve status (e.g., an encoder or other mechanism) may be employed.S404D loops continuously until the condition is met. At S405D, thecontroller 807 activates the water pump 806 causing water to flow intothe water line such that water flows freely under control of the pump808. At S406D, control loops until the valve actuator 822 closecondition is detected. Thereupon, the water source pump 806 is halted atS409. The close condition is caused by the operation in S416C. Thus, thewater source 810 is automatically demand-controlled by the peritonealdialysis fluid preparation device 800 controller 809 without a signalconnection between the controllers 809 and the water source 810controller 807.

In any of the foregoing embodiments in which pressure, voltage, or otherindications are used to control the flow of a fluid, such as water, theupstream source such as fluid source may be placed in a demand mode toenable control by pressure, voltage, or other indications. This may bedone by a unique user command through a connected user interface.Alternatively, the controller (e.g. 807, 739) may generate a commandusing a unique pattern of pressure or final control to a valve or pumppower supply to indicate the demand mode. When not in the demand mode,the fluid source ability to respond to the commands for fluids isdisabled.

Referring now to FIGS. 20A through 20E, any of the foregoing embodimentsmay be modified to employ any one of a variety of locations for a filterthat removes pyrogens and infectious agents such as bacteria. Any of thefilters 824 may be, or include, a single filter, for example with amembrane having pores of 0.2 micron or smaller diameter. Any of thefilters 824 may be, or include, a single filter of the same type withadditional apparatus and/or controls suitable for testing. For example,a pressurized line may permit the application of pressurized air belowthe bubble point of the membrane to one side of the filter to measurethe membrane's ability to withstand the pressure and thereby indicateits integrity. This type of filter integrity test is known in the artand details are known to those skilled in the art. In other embodiments,the filters 824 may be redundant to reduce the probability of a failureto the joint probability of a failure in both filters. In each of theFIGS. 20A through 20E, a patient 842 is filled and drained through apatient fill/drain line 841 via a fluid circuit 856 which may beconfigured in accord with any of the embodiments disclosed herein or inthe embodiments disclosed in the references referenced in theincorporation-by-reference statements. A mixing chamber 855 is connectedto the fluid circuit 856 where the fluid circuit 856 prepares a batchusing inflow 857 and outflow 858 lines with flow direction designated byarrows. As in the foregoing and later embodiments, a water source 850, afirst long-term concentrate container 852, and a second long-termconcentrate container 863 are connected to the fluid circuit 856.

In the embodiment of FIG. 20A, each of the inlet lines for water 826,the first concentrate 852, and the second concentrate 853 have a filter824 to prevent contaminants from entering the fluid circuit 856 andthereby prevent contaminants from entering the patient 842. Theguarantee against contamination provided by the filters 824 is optimizedif all other components are permanently (or previously, as-delivered andsterilized) connected within and to the fluid circuit 856 such that onlyconnections to the water 850, the first concentrate 852, and the secondconcentrate 853 need to be made upstream of the filters 824. Thus, thefilters themselves are attached to the lines 826, 827, and 828. Notethat connectors are not separately shown, but may be provided forconnecting between each of the respective water 850, the firstconcentrate 852, and the second concentrate 853 and the lines 826, 827,and 828 on the fluid-source side of the respective filter 824.

In the embodiment of FIG. 20B, a drain line 861 drains fluid from thefill/drain line 841 and a fill line 862 fills the fill/drain line. Thefill line 862 has a filter 824. In this embodiment, no other filters areused. The fill/drain line 841 is permanently or previously attached tothe fill line 862 prior to sterilization such that when the fill/drainline 862 is connected to the fluid circuit 856 (note that it could bepreviously attached and sterilized as a unit with all or parts of thefluid circuit 856), any contamination, including touch contamination, isblocked from reaching the patient 842 by the filter 824. Other elementsare as described above.

In the embodiment of FIG. 20C, a filter 824 is placed on the mixingcontainer 855 inflow line 857. The mixing container 855 is presumed tobe attached to the fluid circuit before sterilization so that a sealedunit is formed and any touch contamination is prevented from enteringthe mixing container 855. A filter may also be provided on the fill line862 as in the embodiment of FIG. 20B. Alternatively, instead of a filteron the fill line 862, the fluid circuit 856 may be designed such that adedicated channel is defined between the mixing container 855 and thefill line 862 so that unsterile fluids, or fluids not protected bysterile filtration, do not contact any part of the circuit connectingthe mixing container outflow line 858 and the fill line 862. As in otherembodiments, the filter 824 is connected to the downstream portion andpreattached to ensure sterility of the contents of the mixing container855.

In the embodiment of FIG. 20D, the water line 826 and a commonconcentrate line 845 are protected by respective filters 824. Thedownstream side of the water line 826 and the filter 824 may bepreattached to the fluid circuit 856, mixing container 855, and thepatient lines including fill, drain, and fill/drain 861, 862, and 841.The downstream side of the common concentrate line 845 and the filter824 may be preattached to the fluid circuit 856, mixing container 855,and the patient lines including fill, drain, and fill/drain 861, 862,and 841. The preattachment specifies that all these elements are sealedwith each other before sterilization (or during) to ensure the delivereddisposable set is sterile and protected from contamination ingress bythe presence of the filters 824. In this case components upstream of thefilters 824 can be replaced without risk of contamination.

In the embodiment of FIG. 20E, which corresponds to the embodiment ofFIG. 18A, the filter 824 is placed in the common fluid line 827 andpreattached to the remainder of the fluid handling components which arealso interattached. That is the filter 824, the portion of the commonfluid line 827 downstream of the filter 824, the fluid circuit 856,mixing container, and the patient lines including fill, drain, andfill/drain 861, 862, and 841 are all interconnected to form a sealedunit prior to sterilization. This ensures the delivered disposable setis sterile and protected from contamination ingress by the presence ofthe filter 824. In this case components upstream of the filter 824 canbe replaced without risk of contamination of the downstream circuit.

FIG. 20F shows a generalized embodiment similar to that of FIG. 18A inwhich a conductivity sensor 859 is provided on the mixing container 855outflow line 858. The configuration allows the method embodiments hereinto be modified to minimize the total amount of fluid that must be drawnfrom the mixing container 855 toward the drain to measure conductivityof the mixing container 855 contents. The present embodiment may bemodified to provide two conductivity sensors connected in series to beused for volume flow rate measurement as described herein. Note that inany of the embodiments, identified conductivity cells may be of thedirect contact or capacitive type of conductivity cell.

FIG. 20G shows an embodiment similar to that of FIGS. 20E and 20F interms of the filter placement at a common fluid inlet 827. The filter825, in the present embodiment, permits a membrane integrity test whichmay be performed by pressurizing with air from an air pump 835. The pump832 has inlet and outlet pressure sensors 831 and 830 that are used bythe controller 847 for pressure compensation of a commanded rate of pump832 as described with reference to various embodiments including theincorporated reference US Patent Publication 2015-0005699 also attachedto the provisional application. The pump 832 flows fluid betweenmanifolds 833 which may as described in the various embodimentsdescribed herein. In the present embodiment, the controller 847 isconfigured to open any valves necessary to open a fluid channel from thefilter 825 to the pressure sensor 831 and to apply air pressure frompump 835 while monitoring the pressure signal from pressure sensor 831for any change. A filter membrane with no compromise to its integritywill hold the pressure from the air pump 835, which may be controlled tobe maintained below the bubble point of the membrane. The controller 847may generate a signal based on whether a pressure change is indicated bythe pressure sensor 831 or not. By opening a channel to a pressuresensor that provides another function, the need for an additionalpressure sensor may be avoided.

FIGS. 21A through 21C show, respectively, correction procedures forrecovering from incorrect conductivity measurements in the preparationof a batch of dialysate by proportioning two concentrates and water.FIG. 21A shows the flow from, after initially adding up to 100% of therequired amount of water to the mixing container (Refer to FIG. 18A, forexample, noting that the method of FIGS. 21A through 21C can be usedwith other embodiments). Initially, before S602, a fraction (less than100% of target quantity) of water is added to the mixing container, thenat S602, a first concentrate is added, mixed, and a conductivitydetected and determined to be within the expected range (C1 ok). Notethat S648 (FIG. 21B) corresponds to the condition where conductivityafter mixing the initial amount of water and the first concentrate isout of the expected range such that the added quantity of the firstconcentrate indicated to be too high and S688 (FIG. 21C) where theconductivity is out of range indicating the added quantity of the firstconcentrate was too low. In all three cases, water was added to themixing chamber, the contents mixed, and the conductivity tested.

At S606, 100% of the second concentrate C2 is added to the mixingcontainer. At S608 the mixing chamber contents, with the added secondconcentrate C2, is tested and conductivity found to be within theexpected range. S628 corresponds to the condition where conductivity isout of the expected range and the added quantity of the secondconcentrate indicated to be too high and S634 corresponds to where theconductivity is out of range indicating that the added quantity of thesecond concentrate was too low. At S610, both the first and secondconcentrates were added in the correct amounts and the balance, if any,of the water is added to the mixing container and the mixing containerconductivity tested to confirm its usability. At S612, the conductivityis in the expected range indicating proper dilution. If 100% of thewater was previously added prior to S602, then the test can be omitted.S616 and S622 correspond to over-diluted and under-diluted conditions,respectively. If the batch is the correct dilution, then at S614 it ismade available for use. At S616, if the batch is over diluted, there aretwo possible responses. The first response is that the batch can beindicated as failed and an output corresponding to recover operation canbe output. Alternatively, additional concentrates in the same proportionas the target, can be added sequentially to the mixing container asindicated at S618, after which, at S620, the batch is tested again forconductivity and if it fails, the batch is failed or if the conductivityis in range, the batch is made available for use.

Returning to S628, the condition where conductivity is out of theexpected range and the added quantity of the second concentrateindicated to be too high, at S630 an additional quantity (bolus) of eachof the first concentrate and water are calculated in the targetproportions to bring the proportions of these and bring the mixingcontainer contents to the expected range of conductivity. Then, at S632,the balance, if any, of the water is added to the mixing container plusthe water bolus plus the first concentrate bolus (calculated at S630)and the batch's conductivity tested S634 to confirm its usability. Ifthe conductivity is in range, the batch is made available for useotherwise the batch is failed.

Returning to S634, the condition where conductivity is out of theexpected range with the added quantity of the second concentrateindicated to be too low, at S636 an additional quantity (bolus) of thesecond concentrate is calculated to achieve the target proportion tobring the mixing container contents to the expected range ofconductivity. The conductivity is tested again. If the conductivity isnot in the expected range, then at S638, the batch is failed, otherwiseS642, the balance, if any, of the water is added to the mixing containerat S644 and the contents conductivity tested S646 to confirm itsusability. If the conductivity is in range, the batch is made availablefor use otherwise the batch is failed.

Returning to S648 and FIG. 21B, which corresponds to the condition whereconductivity after mixing the initial amount of water and the firstconcentrate is out of the expected range such that the added quantity ofthe first concentrate is indicated to be too high, correction begins atS650. At S650, boluses of the second concentrate and water arecalculated to bring the proportions to the target and at S652, the totalquantity of the first concentrate plus this bolus are added to themixing container. The mixing container contents are then tested at S654and if in range, meaning the second concentrate is in the correctproportion to the first, S656, the balance of the water plus the waterbolus are added and the batch tested at S658. Note that the expectedconductivity at S656 corresponds to a higher concentration of the secondconcentrate than if the first concentrate had been added in the correctamount because the water bolus is not yet added at this point. Thereason for delaying the water addition is that optimally additions tothe mixing container contents are scheduled to coincide with the pointat which the fluid circuit is primed with the fluid corresponding to theone to be added to minimize the time spent priming between switchovers.If the batch conductivity is in the expected range S660, then the batchis released for use. If the batch is over-diluted S664, boluses of thefirst and second concentrate in the required proportion may be added andthe batch further tested at S666 where, if it the conductivity is againout of range, the batch will be failed. In an alternative embodiment, atS664, the batch is simply failed without taking any step to correct. Ifthe batch is under diluted S668, a bolus of water may be added and thebatch further tested at S670 where, if it the conductivity is again outof range, the batch will be failed. In an alternative embodiment, atS668, the batch is simply failed without taking any step to correct.

If the quantity of second concentrate added was indicated by theconductivity measurement S654 to be too great at S672, then at S674, thebatch is failed. In alternative embodiments, a correction may beperformed by adding proportionate boluses of water and the firstconcentrate. In the present embodiment, errors in the first and secondconcentrate additions both occurred indicating the potential for asystem problem, so the system may fail the batch and provideinstructions for testing the system or replacing the fluid circuit,which may be the source of the problem. The controller may perform thisas part of a batch fail recovery process. If the quantity of secondconcentrate added was indicated by the conductivity measurement S654 tobe too low at S676, then at S678, the batch proportions may be recoveredby adding a bolus of the second concentrate at S678 and testing again.If the conductivity of the mixing container is again out of range, thebatch is failed at S682; otherwise, at 686, the balance, if any, of thewater is added to the mixing container and the contents conductivitytested to confirm its usability and made available for use, unless thebatch failed based on the outcome of the conductivity test.

Returning to S688 and FIG. 21C, where the first concentrate added wasfound to be too low, at S690, since the system is already primed withthe first concentrate, an additional amount can be calculated from theconductivity and added. No additional bolus of water is required. Themixing container contents are sampled at S690 and if the conductivity isout of range at S692, then the batch is failed. If the conductivity isin the range S696, the second concentrate target amount is added S698and tested S700. If the mixing container contents conductivity showsthat the correct amount of the second concentrate was added S702, thenthe balance, if any, of the water S704 is added to the mixing containerand the batch contents' conductivity is tested to confirm its usability,and is made available for use if within range S706. If the mixingcontainer contents conductivity is not in range, and the batch is foundto be too dilute S710, then boluses of the first and second concentratesare calculated and added S712 and the batch is tested and used or failedbased on the result. If the batch is found at S704 to be overlyconcentrated, then the conductivity measurement is used to calculate awater bolus S724, which is added, and the contents are tested and usedor failed depending on the result.

If at S700, the second concentrate amount added to the mixing containerwas found to be too high S726, then the batch is failed at S728. Again,this would be caused by two concentrate measurement failures. If atS700, the second concentrate amount added to the mixing container wasfound to be too low S730, then additional second concentrate is added atS734, the batch is tested, and if the conductivity is out of range, thebatch is failed S736. If at S732, the conductivity is in range, then thebalance, if any, of the water S740 is added to the mixing container andthe contents conductivity is tested to confirm its usability and is madeavailable for use if within range.

In alternative embodiments, instead of the procedure being based on thepremise that the volume of concentrate is incorrect, the error may bepresumed to be the concentration (or “strength”) of the concentrate. Theembodiment of FIG. 25 describes an example of a procedure based on thispresumption.

FIGS. 22A and 22B show a water filtration system 551 with cleaning andpriming modes controlled by a water system controller 550 which iscommanded by a proportioner/cycler controller 576 according toembodiments of the disclosed subject matter. A source of raw water 556,such as a source of potable water, is pumped by a pump 552 through aprimary filter 554 which is not cleaned or regenerated, and then througha selected one of a pair of filters 558 and 560 which can be cleaned orregenerated. At any given time, the water system controller 550 controlsthe pump, a four-way reversing valve 570, and flow restrictors 571, 572,and 573 to direct a forward flow of the output of primary filter 554through one of the filters 558 and 560, and directs a reverse outputflow through the other of the filters 558 and 560 to the drain 562,depending on its setting. Output of one the filters 558 and 560 isdivided at a respective one of the junctions at flow restrictors 571 and572 depending on settings of variable flow restrictors 571, 572, and 573such that a fraction (from 0 to 100%) is directed through the branch 574and a remainder toward the outlet 578 so that one filter can produceproduct water to clean the other and for release through outlet 578while the other is being cleaned with product water. The settings of theflow restrictors 571, 572, and 573 make it possible to clean one filterwith all the product water or for both filters to produce product wateruntil a cleaning is required. In FIG. 22A, the arrows show the flow forforward flow through filter 558 and reverse flow of filtered productwater from valve 566 and 568 flowing through the filter 560. In FIG.22B, the arrows show the flow for forward flow through filter 560 andreverse flow of filtered product water from valve 566 and 568 flowingthrough the filter 558. The flow restrictors 571, 572, and 573 may becontrolled by the water system controller 550 which in turn may becommanded by the proportioner/cycler controller 576 of theproportioner/cycler 576 which may be configured according to any of theembodiments disclosed or referenced herein or others.

In addition to the cleaning mode, the water filtration system 551 mayalso have a flushing mode in which water that has remained for too longin the system is diverted by a diverting valve 555 to the drain 562.This operation may be performed on a periodic basis or in response to acondition (such as a time since last use) under control of the watersystem controller 550 of the cycler controller 576. In addition tocleaning and flushing modes, the water filtration system 551 may alsohave priming mode wherein raw water is pumped through both filters 558and 560 in a forward direction with flow restrictor 573 set to fullyopen and flow restrictors 571 and 572 alternating between fully open andpartially restricting so that the branch line 574 is primed. In thismode, all flow may be directed through the drain line 557 by a divertingvalve 555. An air or other type of detector may be provided in the drainline 557 to indicate when the water passing through has beensufficiently cleared by priming. The filters 558 and 560 may also bereverse flushed to drain during the priming sequence.

The filtration system 551 may also have a primary filter stage 554 with,for example, an ultraviolet lamp 559 that is controlled by the watersystem controller 550. The water system controller 550 may optimize lamplife by regulating the lamp's 559 output so that it is cycled on whenrequired (e.g., when water is flowing) and turned off when water is notflowing. The controller 550 or 576 may be configured to turn theultraviolet lamp 559 on just prior to the water pump activation toensure that its output is applied to all water flowing through thestage.

The filtration system 551 may have an off mode, a sleep mode, and anoperating mode. In the off mode, the water system controller 550 andcontrolled flow restrictors 571, 572, and 573, the pump 552, the valves555 and 570 may all be powered down. From the sleep mode, these may bepowered up with the water system controller 550 in a mode in which itcan immediately accept commands and act accordingly. The sleep mode mayalso include regulating the pressure and primed state of the water linessuch that there is minimal delay from the receipt of the command to pumpand deliver product water and the actual output. The water sourcecontroller 550 may transmit to the proportioner/cycler controller 576 asignal indicating a ready status. The water source controller 550 maytransmit a signal, either unprompted or in response to a request fromthe proportioner/cycler controller 576 indicating its operating state.For unprompted signaling, the water source controller 550 may transmit aheartbeat signal that contains the state of the water filtration system551. This heartbeat signal may be periodically cast to theproportioner/cycler controller 576 where communication is unidirectionalfrom the water source controller 550 to the proportioner/cyclercontroller 576. Such cases may be relevant for configurations in whichthe water source controller responds to direct measurements such aspressure signals as described in connection with FIGS. 19A through 19Membodiments. A state signal can indicate various state information suchwhen the water filtration system 551 is performing a flushing or primingoperation or in another non-ready state, the water source controller 550may transmit a state signal indicating so. Additional state informationmay include time left on the filters, expiration of filters, diagnosticinformation such as time taken for priming and flushing operations,smoothness of pressure regulation, power consumption, duty cycle of thesystem over a predefined period, and other information.

The water source controller 550 may regulate the pump and flowrestrictors 571, 572, and 573 to maintain a target pressure at theproduct water outlet 578. This may be based on a closed loop controlmethod with a target pressure which may include and range (deadband). At569 a pressure sensor is indicated in the product water outlet line 578.

The water source controller 550 and proportioner/cycler controller 576may communicate by any suitable device or system. That communication mayunidirectional or bidirectional as indicated above. Either or both ofthe water source controller 550 and proportioner/cycler controller 576may be of the various forms described with reference to FIG. 14.

The water source controller 550 may activate an alarm 575 in response toany conditions indicating a need for intervention or change ofconfiguration. For example, the water source controller 550 may activatean alarm output 575 such as a general purpose user interface (See forexample, display 1018 and speaker 1024) or special purpose output suchas a lamp or annunciator. The water source controller 550 may also,concurrently, output any alarms to its communications link to theproportioner/cycler controller 576. The latter may command the watersource controller 550 to suppress alarm outputs, delay alarm outputs bya predefined interval, or to perform other actions associated withalarms such as the suppression of the local output from the alarm output575. In addition to outputting alarms to the proportioner/cyclercontroller 576, the water source controller 550 may also transmitinstructions for use or instructions for alarm condition recovery to theproportioner/cycler controller 576 for output and use by a userinterface of the proportioner/cycler controller 576. The user interfaceof the proportioner/cycler controller 576 may transmit commands back towater source controller 550 as well by generating an alarm handlerinput/output session on the proportioner/cycler controller 576. Onemechanism for doing this is for the water source controller 550 togenerate a remote session on the user interface of theproportioner/cycler controller 576 whereby the water source controller550 has an ability to control the output and respond to inputs such asmouse and keyboard input, directly, by replicating an adapted model ofthe user interface it generates internally on the user interface of theproportioner/cycler controller 576 functioning as a thin client,effectively. The user interfaces of the water source controller 550 andproportioner/cycler controller 576 are not shown but may be understoodto have one or more of the aspects described with reference to FIG. 14.The water source controller 550 may also generate a troubleshootingsession on the proportioner/cycler controller 576 in the same manner orby simply outputting informational data and instructions in the form ofa decision tree for output and control by the water source controller550.

In alternative embodiments, the water source controller 550 outputs auniform resource locator (URL) with metadata indicating the condition towhich it pertains, for example, a set of conditions may indicate anurgency or priority of the information contained in the URL. Themetadata may be sent in preceding message or may be combined with theURL. The proportioner/cycler controller 576 may have a priority tablestored within that indicates how the proportioner/cycler controller 576handles the URL (or other alarm data) to allow the proportioner/cyclercontroller 576 to determine whether the URL should be accessed anddisplayed immediately, right after a current input/output session, oroutput only after a certain condition is detected by theproportioner/cycler controller 576. In embodiments, the instructions fortroubleshooting the water filtration system 551 are stored in theproportioner/cycler controller 576 and their output is initiated by thereceipt of alarm data from the water source controller 550.

In addition to the above functions, the proportioner/cycler controller576 may indirectly control the water source controller 550 to control aproduct water heater 553 according to certain commands from theproportioner/cycler controller 576. For example, the proportioner/cycler577 may be provided with a fluid heater 579. Such a fluid heater, asknown in various prior art embodiments of peritoneal dialysis cyclers,may be provided to raise the peritoneal dialysis fluid to bodytemperature. Such heaters as 579 may be instantaneous or batch heaters.The heater 579 may heat incoming water, mixtures of concentrate andwater such as ready-to-use medicament, or precursor fluids such aspartially diluted concentrate, or combinations of these. The powerrequirement of a cycler-based heater must be sufficient to raise thetemperature from room temperature to body temperature because typicallyready-to-use bagged dialysis fluid is used for treatment. However, inthe system of FIGS. 22A/22B, the water temperature may be lower thanthat, for example it may be at ground temperature or even near freezingas may come from a domestic tap. In order to reduce the peak powerrequirement of the proportioner/cycler 577 heater, at least part of theheating burden may be shared by the product water heater 553. Note thatproduct water heater 553 may be located at other positions in the flowof water such as the raw water inlet or elsewhere. The product waterheater 553 may be commanded indirectly by the proportioner/cyclercontroller 576 to provide a predefined power output or deliverytemperature. In the case of the latter, the product water heater 553 maybe closed-loop controlled by the water source controller 550 or anothercontroller on a detected output temperature by a temperature sensor 580.

The proportioner/cycler controller 576 may also receive statusinformation from water source controller 550. Such information mayinclude indications that the water filtration system 551 is in flushing,priming, or cleaning mode. Other information may include watertemperature, estimate of time till ready, estimated time left tillfilter replacement (estimated time to exhaustion), time on the UV lamp559, time till next flush or cleaning cycle, and whether the waterfiltration system 551 is in sleep mode and how long the before it isavailable to produce water. This information, because it may indicatereasons for delay, may be useful to provide in real time to a connectedpatient through the user interface of the proportioner/cycler controller576. Additional information output to the proportioner/cycler controller576 user interface may also include forecasting of maintenance taskssuch as filter replacement and ultraviolet bulb 559 replacement. One ormore resistivity sensors may be provided in the product water outletline 578, which may be connected to the water source controller 550 withthe resistivity transmitted as status information to theproportioner/cycler controller 576 and relevant synthesis of thisinformation output on a user interface. For example, such a synthesismay be the display of an alert when the resistivity is out of bounds.The raw water resistivity may be similarly monitored. Since the lifespanof the filters may be affected by the raw water quality, thisinformation may be provided to the proportioner/cycler controller 576and relevant outputs generated in response to it. For example, theproportioner/cycler controller 576 may alert the user to a low waterquality level in the supply which may be mitigated by changes ininfrastructure and at least warn the user that filter replacement mayneed to be frequent.

Some of the functions of the water filtration system 551 can bescheduled with some flexibility without seriously impairing its abilityprovide purified water or causing premature exhaustion or failure ofcomponents such as filters. For example, functions whose timing mayinterfere with a patient's lifestyle may be moved up or delayed in orderto permit the patient to be treated on a schedule that better fits thepatient's life schedule. The user interface of the water sourcecontroller 550 or the proportioner/cycler controller 576 may provide acontrol to allow the user to enter scheduled events such as treatmenttime, treatment duration (e.g., wakeup time), and time ready fortreatment (which requires the line to be primed and connected to thepatient). In embodiments, relevant data such as the patient's treatmentschedule may be entered in the controller, e.g., the proportioner/cyclercontroller 576. In further embodiments, the patient's treatment schedulemay be stored over time and used to estimate future treatment schedulesincluding connect time, bedtime, treatment start time, wake time,treatment end time and any other events associated with treatment andmaintenance normally indicated by the respective controllers (550, 576).The respective controllers 550 (or indirectly as commanded throughproportioner/cycler controller 576) may be controlled to run flushingand cleaning modes at times that lie between certain interfering eventssuch as treatment or to prime the water system a certain interval aheadof a predicted connection of the patient to the proportioner/cycler 577.Note that in embodiments, the water filtration system 551 may have areservoir to receive product water for use on-demand by theproportioner/cycler 577. The heater 553 may, in such embodiments, be abatch heater that applies heat to the reservoir. In such embodiments,the water source controller 550 or proportioner/cycler controller 576may schedule production and storage of purified water in the reservoirand heating thereof according to an estimated time of use for treatment.Such a reservoir may be a disposable component, for example a plasticbag. The reservoir may be sized to receive water for a single cycle,part of a cycle, or multiple cycles of a full treatment. A reservoir maybe provided with a sterilizing filter on its inlet (for touchcontamination), its outlet (to block back-growth contamination), orboth. Check valves may be provided on inlets or outlets or both toprevent backflow. A predefined pressure at the outlet of the reservoirmay be maintained at a constant level by means of a recirculation loopwith a check valve having the predefined cracking pressure.

The water filtration system 551 illustrated shows a very basic example.Many purifiers that create water suitable for peritoneal dialysisinvolve many stages, each with filters having different lifetimes whichmay be affected by the quality of the raw water. In embodiments, thecontrollers 550, 576 indicate estimated exhaustion events for filterssuch as reverse osmosis membranes, carbon filters, ultrafilters,deionization resin beds, sediment filters, or other consumable types offilters. The indications may be based on time, raw water quality, numberof cleaning cycles, etc. Either controller 550 or 576 may be programmedto order replacements for such consumable components and/or consumablesupplies used for treatment automatically. For example, commands forordering supplies may be sent to a server by means of the network 1012(which may include the Internet). Failed components that are notconsumables may also be reported and replacement parts orderedautomatically along with repair orders in the same way.

FIG. 22C shows the water source and associated systems similar to theembodiment of water filtration system 551 described with reference toFIGS. 21A and 21B. A reservoir 581 is fluidly connected to receiveproduct water filtered through a sterilizing filter 582 and a checkvalve 583. The water is supplied to the proportioner/cycler 577 throughan outlet 578 under a predefined pressure maintained by a loop 5851containing a pump 585 and a check valve 584 with cracking pressure setat the predefined pressure. Pressure 569 and temperature 580 sensors maybe located at various positions, including one located to monitor thepredefined pressure. An error in the detected versus expected predefinedpressure may be output as an alarm condition. Other filters 582 andcheck valves 583 may be provided to prevent grow-back contamination andto prevent back flow, respectively.

Note that where both controllers are referenced together as controllers550, 576 it is intended to refer to either water source controller 550or the proportioner/cycler controller 576 acting as a command controllerand the other acting as a slave depending on whether the function isperformed directly or indirectly by the controller and on whether thefunction is performed by the proportioner/cycler 577 or the waterfiltration system 551.

Note that in all the embodiments herein where a cycler is described, aproportioner/cycler may be substituted, i.e., a device that performs asa peritoneal cycler as well as a fluid proportioning device (aka aproportioning device). Note that in all the embodiments herein where aproportioner/cycler is described or identified, a cycler orproportioning device (also called proportioner) may be substituted. Notethat in all the embodiments herein where a proportioner or proportioningdevice or system is described or identified, a cycler or aproportioner/cycler may be substituted.

Note that the present application has generally avoided the terms suchas “admixing” to make the present application clearer. The term“admixing” is suggestive of an intermediate mixture of fluids ratherthan a final mixture such as ready-to-use peritoneal dialysis fluid.

For example, in the present application, applicants have used the termproportioning instead admixing because admixing implies the making of anintermediate product. The term proportioning implies a more generalprocess such as the making of an intermediate product (an admixture) ora final product such as a ready-to-use peritoneal dialysis fluid. Thus,the term proportioning suggests something more general and is adopted inthe present application where in the priority application, the termadmixing was also used in this broader sense. Thus usages of terms suchas “admix,” “admixing,” and “admixer” in the priority applications referto corresponding terms such as “proportion,” “proportioning,” and“proportioner” in the present application. The differences in the termsdoes not modify the subject matter relative to the priorityapplications. The priority applications simply used “admix,” “admixing,”and “admixer” and related terms in a broader sense.

According to the above embodiments, especially those discussed withreference to FIGS. 19A-19M and 22A-22C, there are provided the followingfeatures and embodiments of a system that includes a water source systemwith a controller in combination with a proportioner/cycler or cycler,also with its own controller.

The water system pumps water in response to a demand signal communicatedvia a fluid connection between the water system and theproportioner/cycler. The demand signal may be a detection by the watersystem controller of a change in pressure generated by theproportioner/cycler. The pressure change may be generated by the cyclerpump operation, where the cycler pump is one that is used for fill anddrain of a patient peritoneal cavity, or a pump (if different) used forproportioning, or some other pump controlled by a proportioner/cyclercontroller. The pressure may be a draw-down of pressure caused byforward operation of the proportioner/cycler pump. The water source mayhave a pump which may start when a pressure sensor in a connection tothe proportioner/cycler water system passes a particular (negative)threshold. The water source may have a pressure sensor that detects andconveys signals by way of pressure pulses to the water source controllerwhich decodes them into specific predefined commands One command may befor the water source to start pumping product water into the connectionto the proportioner/cycler. Another command may communicate a value andcommand to which a closed-loop control pressure target of the watersource outlet should be reset. Other aspects of the water source may becommanded, such as a time for the water system to flush, clean, orprime, a future time of treatment, and other parameters identifiedabove. As for closed-loop control of a water source pump, the speed of awater pump that pushes water through one or more filters may be adjustedautomatically in response to an outlet (outlet being the interface tothe proportioner/cycler) or other intermediate pressure of the watersystem. The pressure pulses may be generated by a selected one (or moreif present) cycler/admixer pump(s) that is/are positioned to influencethe pressure at the outlet of the water source. For example, pulses maybe generated by modulating driving power of a pump actuator in astepwise fashion.

In other embodiments, the water source receives commands from theproportioner/cycler. In embodiments, such commands are transmittedand/or exchanged between the water source and the proportioner/cycler byany suitable means for exchanging digital data including wired andwireless. In embodiments, the proportioner/cycler may control thetiming, duration, and type of all water source functions includingpriming and flushing operations. In embodiments, the water sourcecontroller indicates to the proportioner/cycler controller its statusincluding an indication that it is ready to output product water. Inembodiments, the proportioner/cycler controller starts and stops waterproduction. In embodiments, the proportioner/cycler transmits commandsto start and stop an ultraviolet (germicidal) lamp in the water source.In embodiments, the commands may be adapted for extending the life ofsuch an ultraviolet lamp by ensuring it is operated and ready only whenrequired for treatment of water. The proportioner/cycler may use two-waycommunication with the water source to place it in a sleep mode at endof a treatment such that some or all power functions are switched off tosave power and reduce wear. The proportioner/cycler may send commands towake up the water source so that it is ready at a time of a predefinedtreatment stored in the proportioner/cycler. Commands from theproportioner/cycler may also be used to regulate the pressure and flowrate at which product water is delivered. As indicated above, closedloop control based on a pressure signal may be provided by the watersource controller. The two-way communication may support thetransmission of alarms generated by the water source and theproportioner/cycler may respond by ceasing dialysate preparation inresponse to predefined alarms. Alarm or status outputs of the watersource may be used to generate specific outputs through theproportioner/cycler user interface which may have audio and visualoutput capability. The proportioner/cycler user interface may outputguided troubleshooting steps in response to and related to the watersource outputs and alarms, and these may be output to a patient oroperator. The output may be attended by the presentation of inputcontrols to receive relevant feedback to create a guided session.Feedback may include answers to questions about the system such as theobservations about the status of the parameters being checked, such asclosure of fluid connections, proper electrical connections, propermating of tubing with actuators, and instructions to skip to certainsteps.

The proportioner/cycler may control the water source heater and receiveindications of power output, temperature, and ready status. The totalheat required by the product dialysate may be shared by the water sourceand the proportioner/cycler so that the power required of either issplit between the water source and the proportioner/cycler. This may berelevant where the proportioner/cycler heater power is sized to raisethe temperature of premixed dialysate from room temperature to bodytemperature so that the additional power required to raise thetemperature of water from a tap temperature (which may be very low insome cases, such as in northern climates where water mains can havetemperatures near freezing) to room temperature may be borne by thewater source heater. The water source consumable component status(predicted or indicated by sensors) including carbon filters,deionization resins, ultrafilters and others may be indicated by thewater source to the proportioner/cycler and output by the latter's userinterface to inform a user or patient of the need for maintenance andresupply. The controller of the water source or proportioner/cycler maybe programmed to auto-order replacements through the Internet. Thetiming of such auto-order replacements may be done to effect therequired change-out before exhaustion. The estimated time for a neededreplacement may be responsive to the disposable consumption rate,therapy frequency, raw water quality, and order processing/delivery leadtimes.

The priming of the proportioner/cycler may include priming and flushingwith water from the water source. The proportioner/cycler controller maytransmit commands to the water source controller to output water atpressures and flow rates required for the proportioner/cycler to performthese functions. The priming may be preceded by a flushing operationwith purified water to reduce the potential presence of endotoxins inthe disposable fluid circuit.

The water source may include a reservoir sized to provide watersufficient for a fill/drain cycle or for a full treatment (multiplefill/drain cycles). The reservoir may have one or more sterilizing-gradefilters on its inlet (and/or outlet) lines to prevent touchcontamination or back-growth contamination. The reservoir may includeone or more check valves on its outlet lines to prevent backflow. Thedisposable reservoir outlet may include a recirculation loop with a pumpthat maintains a target head pressure useful to maintain consistentdosing.

Referring now to FIG. 24, the proportioner/cycler 800 with the pump 808and fluid circuit 802 is provided for mixing fluids and for performing aperitoneal dialysis treatment. The proportioner/cycler 800 has acontroller 809 for controlling operations involving the fluid circuitdirected at generating dialysate and performing an automated treatment.The fluid source 810 pump 806 conveys fluid to the peritoneal dialysisfluid preparation device 800 through a fluid line 803. A pressure sensor804 detects pressure in the fluid line and applies a correspondingsignal to a controller 807 of the fluid source 810. The controller 807controls a fluid multiplexer 814 that direct a selected one of water, afirst concentrate 811 and a second concentrate 812. The multiplexer 814may have a pump 813. The controller 807 also controls the pump 806 orpumps 806, 813. It will be observed that this is a generalization ofembodiments described elsewhere herein. Each of the controllers 807 and809 has a respective communications modem 668 to permit each tocommunicate wirelessly with a mobile terminal 669 using a wirelessprotocol such as near field communication (NFC). In other embodiments,the mobile terminal is substituted with another type of data-bearingdevice such as a bar code, a QR code, a radio frequency identificationdevice (RFID), or a battery powered transponder. Note that inembodiments, only one modem is used to transfer information to one ofthe controllers 807, 809 which transfers information to the other of thecontrollers 807, 809 by other means. The mobile terminal 669 may be ageneral or special purpose device such as an embedded system device, atablet or a smart phone. The mobile terminal 669 may have an internalmodem to permit it to communicate with the controllers 807 and 809.

In embodiments, the mobile terminal 669 stores prescriptions for atreatment that can be uploaded wirelessly to the controller 807 and 809.The prescriptions may contain parameters including proportions anddilutions of concentrate, tolerance of the proportions, and otherinformation. The prescription may be encoded with information specifyingthe identity of a particular patient. A user of the mobile terminal 669may be a patient, a caregiver, or a doctor. The mobile terminal may havea biometric authentication component such as an iris scanner, afingerprint scanner, a face recognition algorithm, or other. A user mayauthenticate himself to enable the capability for a prescriptiontransfer to a modem 668.

A token 659 may incorporate a NFC, Bluetooth, or other type ofcommunications device to identify and track a person. For example, sucha device may be worn by a patient. The controller(s) 807, 809 mayconfirm the identity of the patient before implementing an uploadedprescription. Such tokens may take the form of tags or labels. The token659 may identify consumable materials used for treatment such asconcentrates and fluid circuits.

As mentioned above, methods above may be based on the premise that thevolume of concentrate is incorrect if a conductivity measurementindicates the target is not matched. This may instead be changed to apresumption that the error arises in the concentration (or strength) ofthe concentrates. Here the presumption is based on the observation thata long storage interval may cause evaporative loss from a typicalbag-type container. This causes the concentration of the concentrate tobe excessive. If the storage interval is much too high, theconcentration may be non-uniform or the conductivity measurement mayindicate excessive time in storage in which case the batch may befailed. The embodiment of FIG. 25 describes an example of a procedurebased on this presumption.

Referring now to FIG. 25, at S802, after a command is received orgenerated by a controller, a fraction (alternatively, all) of a targetquantity of purified water is added to a mixing container. The apparatusmay be as described according to any of the embodiments disclosed orclaimed herein. At S803, a quantity of osmotic agent and partialelectrolyte concentrate may be added. In alternative embodiments, theelectrolyte concentrate may be added first and later the osmotic agentwith or without electrolyte may be added. As discussed above, sinceosmotic agent can have a conductivity signal-suppressing effect, theosmotic agent conductivity change can be used as an indicator ofconcentration. At S806, the conductivity of the mixing containercontents is tested.

It is determined at S808 whether the concentration of the mixingcontainer contents is lower than an expected target (X) or higher than Xby a predefined amount, in which case the mixing container contents maybe failed and not used at S810. Although not presently shown, it shouldbe understood that an error output to a user interface may be generatedby the controller which may include instructions for checking forcertain faults in the system and instructions for recovery. A measuredconductivity that is too high may also be identified and failed. If theconcentration of the mixing container surpasses such a threshold it mayindicate that the contents of the mixing container are insufficientlymixed. Thus, in alternative embodiments a modification may be includedto retry mixing a predefined number of times. The batch may also besubjected to remix trials if the mixing container contents have aconductivity that is too low. This is not illustrated but may be addedreadily as a short additional flow. If the mixing retry attempts fail,the additional flow may terminate (after the predefined number ofretries) and proceed to S810. If the mixing container contentsconductivity is above X (in embodiments, within a predefinedconductivity range), then at S812 the water deficiency may be calculatedfrom the magnitude of the overage and used as a basis for estimating thewater loss for the first concentrate (in this example, osmotic agent,but as indicated above, it could be electrolyte concentrate instead), aswell as the second concentrate. The amount of the second concentrate (C2in the figure) is also adjusted by this measure since to maintain thecorrect ratio of the two solutes, the amount of the second concentrateneeds to be adjusted as well. This is discussed above. This overageestimate may thus be used to calculate the amount of additional waterrequired to add in a final completion step in order to bring theconductivity to the desired level for a final treatment fluid. That is,the same estimate for water deficiency may be used to calculate a waterdeficiency for both concentrates (or the total number of separateconcentrates according to the embodiment).

At S814, the proper quantity of the second concentrate, in the presentexample, the electrolyte concentrate, is added to the mixing container.As indicated, the quantity of the second concentrate is adjusted toaccount for the first concentrate overage as calculated in S812. AtS816, water sufficient to make up for any deficiency calculated in S812is added to the mixing container. Then at S818, the conductivity of themixing container contents is tested, and at S820 the flow branchesresponsively to the result. The batch is failed if the targetconductivity (Y) is too low or, optionally higher than a predefinedlevel beyond the target Y. If the target Y is found, the batch is readyto use. If the conductivity is too high, at S824, additional water maybe calculated and added. Then the conductivity may tested again and ifit fails(< >Y) S828, the batch may be failed. S824-S828 may be omittedin embodiments.

Any of the methods for treatment fluid preparation described herein maybe modified based in part on an analysis of the tolerance stacking. Sucha stacking may take into account different kinds of variability, some ofwhich are not straightforward to derive from the process itself. Forexample, the process analyzed may be defined between the manufacture ofthe input constituents, water and concentrates, and the provision of afinal treatment fluid. However, the analyzed process here is defined toinclude detectable and correctable errors during the process thatprovisions the final treatment fluid and errors that result in alarmsduring treatment. The final impact of errors on the patient's safetyalong with any correction techniques may also be included in theanalysis.

Tolerances may also include ranges resulting from variability in themanufacture of concentrate, which cannot be influenced, tolerances intesting of intermediate and final conductivities, measurement error, andthe required tolerance range of the final product and any other sourcesof variability. The analysis can benefit from creative input andultimately may result in an alteration of the methods. So, an effort wasmade to analyze the above methods based on tolerances throughout.

Note that in the above processes, adjustments to the C2 as a result ofwater loss may not be necessary. That is because the upward adjustmentdue to the higher concentration of C1 may be canceled by the downwardadjustment due to predicted higher concentration of C2. So, theadjustments may be removed from the procedure of FIG. 25 in embodiments.However, in other embodiments, the cancelation may be incomplete ifdifferences in the propensity for water loss of the two concentrates ortheir packaging are different.

Note that in embodiments, average preparation time for batches may beminimized by optimizing the initial quantity of water added to themixing container at S802. In embodiments, adjustments may be found to berare occurrences such that close to 100% of the water may be addedinitially with the expectation that few adjustments and retries will berequired. In practice, time saved by adding 100% of the water at S802may totally compensate for any occasional failed batches that cannot beadjusted to the expected concentration.

In any of the embodiments, where the description refers to theconductivity being equal to the target, it should be understood that“equal to” refers to a predefined range around the target. Inembodiments, the range may be +/−5%, for example.

In any of the embodiments in which conductivity is measured, it shouldbe understood that the conductivity may be numerically compensated fortemperature deviation from a standard conductivity. In any embodimentsin which the conductivity of the mixing container is tested, a mixingoperation may be inserted. In addition, any mixing operation may includemultiple mixing, testing, and remixing trials until a predefined numberof retries is reached.

In any of the embodiments, any of the pumps may be, or include, any of avariety of types including peristaltic pumps, diaphragm pumps, screwpumps, gear pumps, centrifugal pumps, turbine pumps, syringe pumps, orpiston pumps. The foregoing is a list of examples and is not intended tolimit the scope of the present disclosure or the claims below.

In any of the embodiments, the containers of concentrate may be replacedwith online sources of concentrate such as proportioning systems in alarge-scale installation that mixes component ingredients to formconcentrates and provides them from a fixed connector. In any of theembodiments, other sources of fluids may be connected to the fluid flowdirector embodiments described herein. Examples include cleaning fluids,reference testing fluids for calibrating the conductivity sensor orsensors, sample fluids, and fluids for testing membranes such as air. Inany of the embodiments, such other fluids may flow through various partsof the fluid circuit including the drain as described with reference toother fluids.

As the term is used herein, “flow director” is a fluid circuit andassociated actuators effective for selectively creating flow paths andmoving fluids through the flow paths in order to connect fluid channelsor vessels including those connected to sources and consumers,repositories, or other receiving elements. A “fluid circuit” is may beany line or branching element and may contain vessels, chambers, sensorportions, actuator portions, or any other type of fluid confining andcontrolling element.

Any embodiment which recites or shows tubes as portions of a fluidcircuit, fluid channel, or other equivalent may have instead other typesof fluid channel elements such as channels defined in a casting with abonded film layer to close the channels, panels with welded patterns toform fluid channels, non-round ducts, or other types of elements. Thedisclosed tubes may be replaced with such alternative elements to formadditional embodiments.

Any embodiment which identifies peritoneal dialysis fluid may bemodified to form additional embodiments by replacing the componentsidentified with that particular fluid with corresponding fluids to formother medicaments.

Any component or element identified herein as “disposable” may besterile. Sterility may be readily provided and assured at a time of use,by providing components as disposable elements as is known in therelevant field of medical devices.

As used herein, “pre-connected” may refer to the integral combination ofelements or to their connection in such a manner as to form a sterileboundary or permit the provision of a sterile boundary around theirinterior. For example, if a connection of connectors of two elements ismade (i.e., they are pre-connected or pre-connected) and the connectedelements are sterilized as a unit thereafter, the pre-connected orpre-connected elements may protect against the touch contamination thatwould be required if the corresponding connection were made in thefield, for example. When elements are integral they may provide the samebenefit.

As the terms are used herein, electrolyte concentrate may includevarious ionic species as well as non-ionic species as required. As usedherein, osmotic agent concentrate may include any osmotic agent such asglucose or dextrose and may include other species including ionicspecies that may be characterized by the term “electrolytes.”

Any of the embodiments expressly limited to “peritoneal dialysis fluid”may be modified to form additional embodiments by substitution of theterm “dialysate” and making appropriate substitutions for theconstituents. Any embodiments limited to multiple concentrates,including two, may be changed to employ a single concentrate that isdiluted to form a ready-to-use medicament.

Any of the valves or pumps recited herein may be substituted for any ofa variety of types of flow directing and fluid conveying devices. Forexample, a variety of pump and valve types are known and may besubstituted for those described herein. Variations based onsubstitutions of these elements may be made to form additionalembodiments.

As the term is used herein, “in-line” means that an element is in a flowpath. For example, a flow channel with an in-line sterilizing filter issuch that fluid flowing in the flow channel is filtered by the in-linefilter.

A port is any transition for a fluid conveyance such as a channel, tube,integral connection, or connector. Any recitation of “port” may bereplaced with the term “connector” to form variations of the disclosedembodiments.

As used herein, a window is any opening in a curved or flat element. Adrain is any outlet to an external element and may include a storagevessel.

Any sterilizing filter may be embodied as a channel blocked by amicroporous membrane. Such a microporous membrane may have pores whosemaximum size is no greater than a minimum pathogen size. Known thresholdpore sizes are, for example, 0.2 microns.

Any embodiment element identified with the term “daily” may be changedby substitution of other time intervals to form additional embodiments.

Integral or integrally attached refers to elements that are formed of asingle piece or bonded together so as to create a single unit. Elementsidentified as integral may be changed to identify them as “connected” or“attached” to define additional embodiments.

As used herein, a “source” is any container or plant capable ofsupplying a recited fluid. A sink is any destination for a fluid such asa container, a consuming device, or a drain.

As user herein, a “line” is tube or other type of fluid channel. In anyof the embodiments, lines may be tubes such as polymer tubing commonlyused for medical disposable devices.

A “recess” is any concavity. A recess has two ends, an “access” which isthe open end, and a “blind end,” which is the closed end.

Any détente mechanism identified herein may be substituted with any typeof frictional or interference-based mechanism for locking or restrainingone element relative to another to form additional embodiments.

In any of the embodiments, including in the claims, where the integrityof a sterilizing filter is tested, the filter membrane may be subjectedto a pressure-decay test or a bubble-point test. Other types of testssuch as diffusion test and other known techniques may be used.

Any of the embodiments of a dialysis device may have a digitalcontroller that directs the sequence of operation to perform a treatmenton a patient may have a wireless interface that communicates with atransmitter such as a radio frequency identification (RFID) tag,Bluetooth, or a NFC device. Such a device may communicate with awireless-capable appliance such as a cellular phone, tablet, or othercomputer. Using the transmitter, the dialysis device may transfer adigital record of therapy data, such as a treatment log, from thetransmitter. If the transmitter includes a receiver or if a separatereceiver is provided, then the dialysis device may be enabled to receivea prescription for a therapy. For example, a NFC tag or mobile phone maybe used to upload data such as a prescription from a mobile or a passiveNFC tag to the dialysis device. The upload of a data to the dialysisdevice may be accomplished using a passive tag such as an RFID or apassive NFC device.

Other information that may be uploaded to the dialysis device includespatient-identifying information as well as patient classifyinginformation. The dialysis device may upload information about thedialysis system for diagnostic purposes using any of the wirelessprotocols. The dialysis device may transfer data by wireless protocolssuch as 802.11 a/b/g/ac/n and Bluetooth. The dialysis device maydownload system logging or diagnostic data from the dialysis device tothe cellular phone, tablet, or other computer using any of the wirelessprotocols. The dialysis device may download treatment summary data tothe cellular phone, tablet, or other computer using any of the wirelessprotocols.

According to first embodiments, the disclosed subject matter includes amethod for making a batch of peritoneal dialysis solution sufficient forat least a single patient fill operation, the batch being a finalmixture of constituents, the constituents including a final quantity ofwater, a final quantity of osmotic agent concentrate, and a finalquantity of electrolyte concentrate. The method includes using a fluidproportioning device with a controller, actuators, and a conductivitysensor and attaching a fluid circuit to the actuators, the fluid circuithaving a mixing container. The method includes using the controller tocontrol the actuators: pumping a fraction of the final quantity of waterinto the mixing container; pumping more than the final quantity, plus orminus an error, of electrolyte concentrate into the mixing container;mixing contents of the mixing container; sampling the contents of themixing container in a manner that reduces volume of fluid in the mixingcontainer and measuring the conductivity thereof; calculating andstoring data responsive to a deviation of the measured conductivity froma predefined expected conductivity resulting from the error; calculatingan adjusted quantity of water and/or osmotic agent concentrate requiredto achieve predefined proportions of the constituent final quantitiesresponsive to the data; and pumping the adjusted quantity of water orosmotic agent concentrate into the mixing container.

In variations thereof, the first embodiments include ones in which themethod is performed at a location of a peritoneal dialysis treatment. Invariations thereof, the first embodiments include ones in which themethod is performed at a time of a peritoneal dialysis treatment. Invariations thereof, the first embodiments include ones in which themethod is performed such that it is completed within a day, within 12hours, within 6 hours, within 3 hours, or within an hour of a start of aperitoneal dialysis treatment. In variations thereof, the firstembodiments include ones in which the fluid proportioning device islocated in a same room, within 100 meters, within 10 meters, within 5meters, or within 2 meters as a patient receiving a peritoneal dialysistreatment.

In variations thereof, the first embodiments include ones in which theelectrolyte concentrate is pumped into the mixing concentrate after thefraction of the final quantity of water; the mixing takes place afterthe pumping of the more than the final quantity of electrolyteconcentrate; the sampling takes place after the mixing; the calculatingand storing data take place after the sampling; the calculating theadjusted quantity takes place after the calculating and storing thedata; and the pumping the adjusted quantity takes place after thecalculating the adjusted quantity.

In variations thereof, the first embodiments include ones in which theusing a fluid proportioning device includes providing a peritonealdialysis cycler. In variations thereof, the first embodiments includeones that include, after pumping the adjusted quantity of water and/orosmotic agent concentrate, sampling the contents of the mixing containerand measuring a final conductivity thereof. In variations thereof, thefirst embodiments include ones that include comparing a finalconductivity to a predefined final conductivity and permitting use ofthe batch or preventing use of the batch responsively to a resultthereof. In variations thereof, the first embodiments include ones inwhich the fraction of the final quantity of water pumped into the mixingcontainer is less than 60%. In variations thereof, the first embodimentsinclude ones in which the controller samples the mixing containercontents by pumping a sample from the mixing container across aconductivity sensor in a drain line. In variations thereof, the firstembodiments include ones in which the fraction of the final quantity ofwater pumped into the mixing container is less than 90%. In variationsthereof, the first embodiments include ones in which the pumping morethan the final quantity, plus or minus an error, of electrolyteconcentrate occurs before the pumping the adjusted quantity of water orosmotic agent concentrate into the mixing container.

According to second embodiments, the disclosed subject matter includes amethod for making a batch of peritoneal dialysis solution sufficient fora patient fill operation, the batch being a mixture of constituents intarget proportions, the constituents including water, osmotic agentconcentrate, and electrolyte concentrate. The method includes using afluid proportioning device with a controller, actuators, and aconductivity sensor. The method includes attaching a fluid circuit tothe actuators, the fluid circuit having a mixing container. The methodincludes using the controller to control the actuators: pumping waterinto the mixing container; pumping electrolyte concentrate into themixing container in an amount intended to create a predefined ratio ofthe electrolyte concentrate and the water; mixing contents of the mixingcontainer; sampling the contents of the mixing container and measuring aconductivity thereof; calculating and storing data responsive to adeviation of a measured conductivity of the mixing container contentsfrom one corresponding to the predefined ratio; calculating an adjustedquantity of water or osmotic agent concentrate responsively to the data;and pumping the adjusted quantity of water or osmotic agent concentrateinto the mixing container.

In variations thereof, the second embodiments include ones in which themethod is performed at a time of a peritoneal dialysis treatment. Invariations thereof, the second embodiments include ones in which theusing a fluid proportioning device includes providing a peritonealdialysis cycler. In variations thereof, the second embodiments includeones that include, after pumping the adjusted quantity of water orosmotic agent concentrate, sampling the contents of the mixing containerand measuring a final conductivity thereof. In variations thereof, thesecond embodiments include ones that include, comparing the measuredfinal conductivity to a predefined final conductivity and permitting useof the contents of the mixing container or preventing use of thecontents of the mixing responsively to a result thereof. In variationsthereof, the second embodiments include ones that include adding furtherwater to the mixing container to create ready-to-use dialysate therein,wherein the adding water into the mixing container transfers less than60% of the quantity of water in the ready-to-use dialysate in the mixingcontainer. In variations thereof, the second embodiments include ones inwhich the controller samples the mixing container contents by pumping asample from the mixing container across a conductivity sensor in adrain.

According to third embodiments, the disclosed subject matter includesmethod for making a batch of peritoneal dialysis solution sufficient forleast a single patient fill operation, the batch being a final mixtureof constituents, the constituents including a final quantity of water, afinal quantity of osmotic agent concentrate, and a final quantityelectrolyte concentrate, wherein the osmotic agent concentrate includesa predefined proportion of electrolyte. The method includes providing afluid proportioning device with a controller, actuators, and aconductivity sensor. The method includes attaching a fluid circuit tothe actuators, the fluid circuit having a mixing container. The methodincludes using the controller to control the actuators: pumping afraction of the final quantity of water into the mixing container;pumping more than the final quantity, plus or minus an error, of osmoticagent concentrate into the mixing container; mixing contents of themixing container; sampling the contents of the mixing container in amanner that reduces volume of fluid in the mixing container andmeasuring the conductivity thereof; calculating and storing dataresponsive to a deviation of the measured conductivity from a predefinedexpected conductivity resulting from the error; calculating an adjustedquantity of water and/or electrolyte concentrate required to achievepredefined proportions of the constituent final quantities; and pumpingthe adjusted quantity of water and/or electrolyte concentrate into themixing container.

In variations thereof, the third embodiments include ones in which themethod is performed at a location of a peritoneal dialysis treatment. Invariations thereof, the third embodiments include ones in which themethod is performed at a time of a peritoneal dialysis treatment. Invariations thereof, the third embodiments include ones in which themethod is performed such that it is completed within a day, within 12hours, within 6 hours, within 3 hours, or within an hour of a start of aperitoneal dialysis treatment. In variations thereof, the thirdembodiments include ones in which the fluid proportioning device islocated in a same room, within 100 meters, within 10 meters, within 5meters, or within 2 meters as a patient receiving a peritoneal dialysistreatment. In variations thereof, the third embodiments include onesthat include providing a peritoneal dialysis cycler. In variationsthereof, the third embodiments include ones that include, after pumpingthe adjusted quantity of water and/or electrolyte concentrate, samplingthe contents of the mixing container and measuring a final conductivitythereof. In variations thereof, the third embodiments include ones thatinclude comparing the final conductivity to a predefined finalconductivity and permitting use of the batch or preventing use of thebatch responsively to a result thereof. In variations thereof, the thirdembodiments include ones in which the fraction of the final quantity ofwater pumped into the mixing container is less than 60%. In variationsthereof, the third embodiments include ones in which the controllersamples the mixing container contents by pumping a sample from themixing container across a conductivity sensor in a drain line. Invariations thereof, the third embodiments include ones in which thefraction of the final quantity of water pumped into the mixing containeris less than 90%. In variations thereof, the third embodiments includeones in which the pumping more than the final quantity, plus or minus anerror, of osmotic agent concentrate occurs before occurs before thepumping the adjusted quantity of water and/or electrolyte concentrateinto the mixing container.

According to fourth embodiments, the disclosed subject matter includesmethod for making a batch of peritoneal dialysis solution sufficient forat least a single patient fill operation, the batch being a finalmixture of constituents, the constituents including a final quantity ofwater, a final quantity of osmotic agent concentrate, and final quantityof electrolyte concentrate, the method, using a controller of aperitoneal dialysis treatment delivery system. The method includes

(a) adding a fraction of the final quantity of water and a firstconcentrate, the first concentrate being one of osmotic agentconcentrate or electrolyte concentrate, to a mixing container and mixingcontents of the mixing container;

(b) measuring a conductivity of the contents of the mixing container andif within a first predefined range, skipping to (d);

(c) computing a new final quantity of a second concentrate, the secondconcentrate being the other of osmotic agent concentrate or electrolyteconcentrate to add to the mixing container responsively to an error ofthe measuring, the error being in a proportion of the first concentratedetected and the fraction of the final quantity of water measured in(b);

(d) adding the second concentrate to the mixing container and mixing thecontents of the mixing container;

(e) measuring a conductivity of the contents of the mixing container andif the measured conductivity is within a second predefined range,skipping to (h)

(f) generating a command to terminate the making of the batch if a newfinal quantity of the second concentrate was computed in (c); otherwise,computing a first supplemental amount of the second concentrate or waterto bring the conductivity to a second predefined range;

(g) measuring a conductivity of the contents of the mixing container andif not within a third predefined range, computing a second supplementalamount of the first and second concentrates or water to add to bring theconductivity within the predefined range; and

(h) adding one or more further quantities of water, the firstconcentrate, and/or the second concentrate sufficient to achieve theproportions of the final mixture, responsively to the first and/orsecond supplemental amounts if computed.

In variations thereof, the fourth embodiments include ones in which themethod is performed at a time of a peritoneal dialysis treatment. Invariations thereof, the fourth embodiments include ones in which themethod is performed at a location of a peritoneal dialysis treatment. Invariations thereof, the fourth embodiments include ones in which, if thecontents of the mixing container are not within the third predefinedrange in (g) then generating a command to terminate the making of thefinal mixture. In variations thereof, the fourth embodiments includeones that include, in response to the command to terminate the making ofthe batch, preventing the use of the final mixture. In variationsthereof, the fourth embodiments include ones that include using thefinal mixture to perform a fill cycle of a peritoneal dialysistreatment. In variations thereof, the fourth embodiments include onesthat include testing a sterilizing filter through which at least onecomponent of the contents of the mixing container flows and generating acommand to terminate the method if the test indicates a failure. Invariations thereof, the fourth embodiments include ones in which thetesting includes applying pressurized air to a wetted membrane andmeasuring a pressure.

According to fifth embodiments, the disclosed subject matter includesmethod of making a dialysate. The method includes adding water and afirst concentrate (C1) to a mixing container, measuring a firstconductivity of the mixing container contents, and if the firstconductivity of the contents of the mixing container is in a firstrange, adding a second concentrate (C2), measuring a second conductivityof the contents of the mixing container, and if the second conductivityis in a second range further diluting the contents of the mixingcontainer. The method includes measuring a third conductivity of thecontents of the mixing container and if the third conductivity is in athird range, using the contents of the mixing container for a treatment;otherwise, if the third conductivity is lower than the third range,adding C1 and C2, and if the third conductivity is higher than the thirdrange, further diluting the contents of the mixing container. The methodincludes, if the second conductivity of the contents of the mixingcontainer is higher than the second range, adding C1 and water inamounts that are responsive to the second conductivity and if the secondconductivity of the contents of the mixing container is lower than thesecond range, adding C2 in an amount that is responsive to the secondconductivity.

In variations thereof, the fifth embodiments include ones that include,if after adding C1 to the mixing container the first conductivity higherthan the first range, calculating an additional amount of C2 to add tothe mixing container responsive to the first conductivity. In variationsthereof, the fifth embodiments include ones that include, if afteradding C1 to the mixing container the first conductivity higher than thefirst range, calculating an additional amount of C1 to add to the mixingcontainer responsive to the first conductivity. In variations thereof,the fifth embodiments includes ones that include if after adding C1 tothe mixing container the first conductivity higher than the first range,calculating an additional amount of C1 to add to the mixing containerresponsive to the first conductivity. In variations thereof, the fifthembodiments include ones that include mixing the contents of the mixingcontainer prior to determining the first or the second conductivity.

According to sixth embodiments, the disclosed subject matter includes amethod of generating a batch of treatment fluid, the method includingusing a controller that stores a treatment prescription, and accordingto the prescription, pumping a calculated ratio of water and electrolyteconcentrate into a mixing container by regulating a pump to control anet volume of each that is transferred to the mixing container. Thecontroller further stores reference data indicating conductivity ofpredefined dilution ratios of water and the electrolyte concentrate. Themethod includes testing a conductivity of the contents of the mixingcontainer resulting from the pumping and further pumping water orelectrolyte concentrate responsively to the testing if the conductivitydiffers by more than a defined threshold from the conductivity indicatedby the stored reference data and controlling a further use of a pump topermit the contents of the mixing container to be used thereafter, orimmediately controlling a further use of the pump to permit the contentsof the mixing container to be used if the conductivity differs by lessthan the defined threshold.

In variations thereof, the sixth embodiments include ones that include,after the pumping a predefined quantity of water and electrolyteconcentrate, mixing contents of the mixing container. In variationsthereof, the sixth embodiments include ones that include using thecontroller to measure temperature of the fluid from the mixingcontainer. In variations thereof, the sixth embodiments include onesthat include using the controller to measure temperature of the fluidfrom the mixing container, temperature-compensate the conductivity,calculate whether the conductivity falls under the threshold to generatea pass/fail result, and outputting one of a command to change a lateraddition of water or concentrate responsively to the pass/fail resultand a command to stop preparation of the batch responsively to thepass/fail result. In variations thereof, the sixth embodiments includeones that include, using the controller to measure temperature of thefluid from the mixing container, temperature-compensating theconductivity, calculating whether the conductivity falls under thethreshold to generate a pass/fail result, and outputting one of acommand to change the later addition of water or concentrateresponsively the pass/fail result and a command to stop preparation ofthe batch responsively to the pass/fail result, wherein the thresholdindicates a conductivity of a diluted osmotic agent electrolyteconcentrate.

According to seventh embodiments, the disclosed subject matter includesmethod of making a batch of peritoneal dialysis fluid. The methodincludes providing a controller connected to receive signals from aconductivity sensor, the controller storing target conductivities ofpredefined target ratios of first and second fluids at a bodytemperature of a human, the controller further storing a correctionfactor that indicates a rate of change of conductivity with temperature.The method includes using the controller, in no particular order, addinga predefined volume of the first fluid to a container and adding thesecond fluid to the container having a composition different from thefirst. The method includes mixing the first and second fluids in thecontainer to create an in-process mixture. The method includes warmingthe first and second fluids to a temperature within a predefined rangeof the body temperature either prior to, during, or after the adding ormixing. The method includes measuring a current conductivity and acurrent temperature of the in-process mixture from the container. Themethod includes using the controller, selecting one of the predefinedtarget ratios corresponding to a current target in-process mixture andcalculating an additional amount of the first or second fluid to add tothe container to achieve the selected one of the predefined targetratios responsively to the current conductivity, the currenttemperature, and the correction factor; and adding the additional amountto the container.

In variations thereof, the seventh embodiments include ones in which thecontroller stores correction factors for each of the predefined targetratios and the calculating an additional amount is responsive to acorrection factor corresponding to the selected one of the predefinedtarget ratios. In variations thereof, the seventh embodiments includeones in which the container stores a batch of peritoneal dialysis fluid.In variations thereof, the seventh embodiments include ones that includeadding a predefined volume of a third fluid at a time before, during, orafter the adding the additional amount. In variations thereof, theseventh embodiments include ones in which the adding the additionalamount includes adding one of water and electrolyte concentrate. Invariations thereof, the seventh embodiments include ones in which theadding the additional amount includes adding one of water and aconcentrate including an osmotic agent. In variations thereof, theseventh embodiments include ones in which the osmotic agent concentrateincludes electrolyte. In variations thereof, the seventh embodimentsinclude ones in which the first fluid is water and the second fluid is amixture of electrolytes for peritoneal dialysis fluid. In variationsthereof, the seventh embodiments include ones in which the first fluidis water and the second fluid is a mixture of electrolytes and osmoticagent for peritoneal dialysis fluid. In variations thereof, the seventhembodiments include ones in which the predefined target ratios areconcentrations of electrolytes in water.

According to eighth embodiments, the disclosed subject matter includesmedicament preparation system. A proportioning element that preparesmedicament from concentrate and water. A proportioning elementcontroller connects to the proportioning element and configured tocontrol functions thereof. A water preparation element is configured topurify water and has a product water output connected to convey water tothe proportioning element. A water preparation element controllerconnects to the water preparation element and is configured to controlfunctions thereof. The water preparation element controller iscontrolled by the proportioning controller such that functions of thewater preparation element are controlled by the proportioningcontroller.

In variations thereof, the eighth embodiments include ones in which thewater preparation element functions include a filter regenerationfunction and the filter regeneration function is controlled by theproportioning element controller. eighth the water preparation elementhas a reversing valve and the proportioning element controller controlsthe reversing valve.

In variations thereof, the eighth embodiments include ones in which thewater preparation element is configured to divert at least a fraction ofits product water through a one of multiple filter units therein toregenerate the one of multiple filter units. In variations thereof, theeighth embodiments include ones in which the water preparation elementincludes an ultraviolet lamp, the proportioning element controller beingconfigured to cycle the ultraviolet lamp in order to eliminate or reduceoutput when water is not being filtered. In variations thereof, theeighth embodiments include ones in which the water preparation elementhas a product water heater and the proportioning element controller isconfigured to regulate a temperature of product water received by it bycycling the product water heater. In variations thereof, the eighthembodiments include ones in which the proportioning element has aproportioning heater that heats fluid flowing therethrough. Invariations thereof, the eighth embodiments include ones in which theproportioning element controller controls the product water heater andthe proportioning heater to share a net heating demand between theproduct water heater and the proportioning heater. In variationsthereof, the eighth embodiments include ones in which the waterpreparation element has a product water heater and the proportioningelement controller is configured to regulate a temperature of productwater received by it by cycling the water heater. In variations thereof,the eighth embodiments include ones in which the proportioning elementhas a proportioning heater that heats fluid flowing therethrough. Invariations thereof, the eighth embodiments include ones in which theproportioning element controller controls the product water heater andthe proportioning heater to share a net heating demand between theproduct water heater and the proportioning heater. In variationsthereof, the eighth embodiments include ones in which the proportioningelement includes a treatment element.

In variations thereof, the eighth embodiments include ones in which thetreatment element includes a dialysis machine. In variations thereof,the eighth embodiments include ones in which the treatment elementincludes a dialysis cycler. In variations thereof, the eighthembodiments include ones in which the treatment element includes aperitoneal dialysis cycler. In variations thereof, the eighthembodiments include ones in which the proportioning element controllerreceives status information from the water preparation elementcontroller. In variations thereof, the eighth embodiments include onesin which the proportioning element controller includes a user interfaceand the proportioning element controller derives information from thestatus information and outputs derived data on the user interface, thederived data including indications that a filter of the waterpreparation element is in a flushing, priming, or cleaning mode. Invariations thereof, the eighth embodiments include ones in which theproportioning element controller includes a user interface and theproportioning element controller derives information from the statusinformation and outputs derived data on the user interface, the deriveddata including indications of water temperature or estimate of timedelay till product water is available. In variations thereof, the eighthembodiments include ones in which the proportioning element controllerincludes a user interface and the proportioning element controllerderives information from the status information and outputs derived dataon the user interface, the derived data including indications ofestimated time left till filter replacement (estimated time toexhaustion).

In variations thereof, the eighth embodiments include ones in which theproportioning element controller receives status information from thewater preparation element controller, the proportioning elementcontroller includes a user interface, and the proportioning elementcontroller derives information from the status information and outputsderived data on the user interface, the derived data includingindications or amount of life left on the ultraviolet lamp. Invariations thereof, the eighth embodiments include ones in which theproportioning element controller includes a user interface and theproportioning element controller derives information from the statusinformation and outputs derived data on the user interface, the deriveddata including indications time till a next flush or a next cleaningcycle of the water preparation element. In variations thereof, theeighth embodiments include ones in which the proportioning elementcontroller includes a user interface and the proportioning elementcontroller derives information from the status information and outputsderived data on the user interface, the derived data including anindication whether the water preparation element is in a sleep modeand/or how long the before it is available to produce water.

In variations thereof, the eighth embodiments include ones in which theproportioning element controller includes a user interface and theproportioning element controller derives information from the statusinformation and outputs derived data on the user interface, the deriveddata including forecasts of maintenance tasks such as filterreplacement. In variations thereof, the eighth embodiments include onesin which the proportioning element controller receives statusinformation from the water preparation element controller, theproportioning element controller includes a user interface, and theproportioning element controller derives information from the statusinformation and outputs derived data on the user interface, the deriveddata including a forecast of a time for ultraviolet lamp replacement. Invariations thereof, the eighth embodiments include ones in which theproportioning element controller includes a user interface and theproportioning element controller derives information from the statusinformation and outputs derived data on the user interface, one or moreresistivity sensors being provided in a product water outlet line thederived data including resistivity of the product water. In variationsthereof, the eighth embodiments include ones in which the proportioningelement controller includes a user interface and the proportioningelement controller derives information from the status information andoutputs derived data on the user interface, one or more resistivitysensors being provided in a product water outlet line the derived dataincluding an alert when the resistivity is out of a predefined range.

In variations thereof, the eighth embodiments include ones in which theproportioning element controller includes a user interface and theproportioning element controller derives information from the statusinformation and outputs derived data on the user interface, one or moreresistivity sensors being provided in a tap water inlet line the deriveddata including an alert when the resistivity is out of a predefinedrange. In variations thereof, the eighth embodiments include ones inwhich the derived data may be an estimate of filter life based onresistivity of water in the water inlet line. In variations thereof, theeighth embodiments include ones in which the water preparation elementhas an off mode, a sleep mode, and an operating mode. In variationsthereof, the eighth embodiments include ones in which the proportioningelement controller and the water preparation element controllercommunicate over a network. In variations thereof, the eighthembodiments include ones in which the proportioning element controllerand the water preparation element controller communicate over a signalcable. In variations thereof, the eighth embodiments include ones inwhich the proportioning element controller and the water preparationelement controller communicate over a wireless connection. In variationsthereof, the eighth embodiments include ones in which the waterpreparation element controller indicates to the proportioning elementcontroller its status including an indication that the water preparationelement is ready to output product water.

In variations thereof, the eighth embodiments include ones in which theproportioning element controller starts and stops water production byapplying commands to the water preparation element controller. Invariations thereof, the eighth embodiments include ones in which theproportioning element controller transmits commands to start and stop anultraviolet (germicidal) lamp in the water preparation element. Invariations thereof, the eighth embodiments include ones in which thecommands are effective for extending a life of such an ultraviolet lampby ensuring the lamp is operated only when required for treatment ofwater. In variations thereof, the eighth embodiments include ones inwhich the commands are effective for extending a life of such anultraviolet lamp by ensuring the lamp is operated only when water isbeing filtered. In variations thereof, the eighth embodiments includeones in which the proportioning element controller employs two-waycommunication with the water preparation element to place the waterpreparation element in a sleep mode at an end of a treatment such thatsome or all power functions thereof are switched off to save power andreduce wear. In variations thereof, the eighth embodiments include onesin which the proportioning element controller may send commands to wakeup the water preparation element so that it is ready at a time of apredefined treatment stored in the proportioning element controller. Invariations thereof, the eighth embodiments include ones in whichcommands from the proportioning element controller regulate a pressureand flow rate at which product water is delivered by the waterpreparation element.

In variations thereof, the eighth embodiments include ones in whichclosed loop control based on a pressure signal is provided by the waterpreparation element controller. In variations thereof, the eighthembodiments include ones in which the proportioning element controlleremploys two-way communication with the water preparation element totransmit alarms generated by the water preparation element and theproportioning responds by ceasing dialysate proportioning in response topredefined alarms. In variations thereof, the eighth embodiments includeones in which alarm or status outputs of the water preparation elementare effective to generate specific outputs through a user interface ofthe proportioning element controller. In variations thereof, the eighthembodiments include ones in which the proportioning element controllerhas a user interface that outputs guided troubleshooting steps inresponse to and related to outputs and alarms of the water preparationelement controller. In variations thereof, the eighth embodimentsinclude ones in which the water preparation element has a water heaterand the proportioning element controller controls the water heater andreceives indications from the water preparation element controller of apower output of the water heater, water temperature, and status of thewater preparation element.

In variations thereof, the eighth embodiments include ones in which thewater preparation element controller is configured to auto-orderreplacements filters through the Internet. In variations thereof, theeighth embodiments include ones in which a timing of the auto-orderreplacements is such as to effect a required change-out beforeexhaustion of the filters being replaced. In variations thereof, theeighth embodiments include ones in which the proportioning element has apriming mode in which flushes a fluid circuit thereof with water fromthe water preparation element. In variations thereof, the eighthembodiments include ones in which the proportioning element controllertransmits commands to the water preparation element controller to outputwater at pressures and flow rates required for the proportioningelement. In variations thereof, the eighth embodiments include ones inwhich the priming is preceded by a flushing operation with purifiedwater to minimize endotoxins in the fluid circuit. In variationsthereof, the eighth embodiments include ones in which the waterpreparation element includes a reservoir sized to provide watersufficient for a fill/drain cycle or for a full treatment (multiplecycles). In variations thereof, the eighth embodiments include ones inwhich the reservoir has one or more sterilizing-grade filters on itsinlet (and/or outlet) lines to prevent touch contamination orback-growth contamination. In variations thereof, the eighth embodimentsinclude ones in which the reservoir includes one or more check valves onits outlet lines to prevent backflow. In variations thereof, the eighthembodiments include ones in which an outlet of the reservoir includes arecirculation loop with a pump that maintains a target head pressure.

According to ninth embodiments, the disclosed subject matter includessystem for performing peritoneal dialysis with a fluid circuit with atleast one fluid inlet and a mixing container. A peritoneal dialysissystem has a peritoneal dialysis system controller, valve actuators, oneor more pumps, to pump and direct concentrate and water selectivelythrough at least at times and through portions of the fluid circuit totransfer concentrate and water, through the at least one fluid inlet, tothe mixing container to form dialysis fluid. A water supply source has awater pump, the water pump being controlled by a water supply controllerand being connected to a purified water outlet which is in turnconnected to the at least one fluid inlet. A command interface isbetween the peritoneal dialysis system controller and the water supplycontroller, the peritoneal dialysis system controller transmitting oneor more commands to the water supply controller to start and stop thewater pump.

In variations thereof, the ninth embodiments include ones in which theone or pumps are configured to pump concentrate and water from one ormore sources.

According to tenth embodiments, the disclosed subject matter includessystem for performing peritoneal dialysis. A fluid circuit has a singlefluid inlet and a mixing container. A peritoneal dialysis system has aperitoneal dialysis system controller, valve actuators, and a cyclerpump that pumps concentrate and water within the fluid circuit. A watersource with a water pump and a concentrate source with a concentratepump are connected to pump water and concentrate through the fluid inletunder control of a fluid source controller connected to control thewater and concentrate pumps. A command interface is connected betweenthe peritoneal dialysis system controller and the fluid sourcecontroller, the peritoneal dialysis system controller transmitting oneor more commands to the fluid source controller to start and stop thewater source and concentrate source pumps.

According to eleventh embodiments, the disclosed subject matter includessystem for performing peritoneal dialysis. A fluid circuit has at leastone fluid inlet and a mixing container. A peritoneal dialysis system hasa controller, valve actuators, one or more pumps, to pump and directconcentrate and water selectively through the fluid circuit to transferconcentrate and water, through the fluid inlet, to the mixing containerto form dialysis fluid. A peritoneal dialysis cycler has actuators,including a cycler pump actuator, to direct concentrate and waterselectively through the fluid circuit to transfer concentrate and waterfrom one or more external sources, through the fluid inlet, to themixing container to form dialysis fluid. A water supply source with awater pump having a purified water outlet connected to the at least onefluid inlet. The water supply source has a water source controller thatcontrols the water pump responsively to at least one sensor that detectsat least one operating condition of the peritoneal dialysis cycler. Thewater source controller activates the water pump when the operatingcondition indicates a requirement for water by the peritoneal dialysiscycler.

In variations thereof, the eleventh embodiments include ones in whichoperating condition includes an activation of an actuator of theperitoneal dialysis cycler that controls the opening of the fluid inlet.In variations thereof, the eleventh embodiments include ones in whichthe operating condition includes the activation of the peritonealdialysis cycler pump actuator. In variations thereof, the eleventhembodiments include ones in which the at least one sensor includes apressure sensor that provides pressure signals to the water sourcecontroller, the water pump being controlled responsively to the pressuresignals such that when the cycler pump actuator is activated to drawwater from the at least one fluid inlet thereby generating a reductionin pressure in the at least one fluid inlet while the water pump is off,the water pump is turned on by the water source controller In variationsthereof, the eleventh embodiments include ones in which the water pumpis turned on by the water source controller when the reduction reaches apredefined magnitude stored by the water source controller. Invariations thereof, the eleventh embodiments include ones in which thewater source controller controls the water pump to maintain the pressureof the at least one fluid inlet within a predefined range of pressures.

According to twelfth embodiments, the disclosed subject matter includesa system for performing peritoneal dialysis. A fluid circuit has a fluidinlet and a mixing container. A peritoneal dialysis cycler has a cyclercontroller, actuators, including a cycler pump actuator, to directconcentrate and water selectively through the fluid circuit to transferconcentrate and water, through the fluid inlet, to the mixing containerto form dialysis fluid. A water supply source has a water pump having apurified water outlet connected to the at least one fluid inlet. Thepurified water outlet has a pressure sensor and a water sourcecontroller that receives pressure signals from the pressure sensor andcontrols the water pump responsively to the pressure signals, the cyclerpump actuator generating coded pressure pulses in the fluid inlet thatare received by the pressure sensor and decoded by the water sourcecontroller to command the water source controller to activate anddeactivate the water pump responsively to decoded commands encoded inthe pressure signals.

In variations thereof, the twelfth embodiments include ones in which thecoded pressure pulses encode changes to operating parameters of thewater source controller including a closed-loop pressure set point atthe fluid inlet. In variations thereof, the twelfth embodiments includeones in which the coded pressure pulses encode changes to operatingparameters of the water source controller. In variations thereof, thetwelfth embodiments include ones in which the water source controllercontrols the water pump to maintain the pressure of the at least onefluid inlet within a predefined range of pressures.

According to thirteenth embodiments, the disclosed subject matterincludes method for making a peritoneal dialysis fluid, the methodincluding connecting a fluid circuit to a proportioning machine, thefluid circuit including a mixing container. The proportioning machinehas actuators that engage with the fluid circuit when received thereby.The method includes connecting a water source and one or more freshcontainers of concentrate to the fluid circuit, each of the one or morefresh containers of concentrate having sufficient concentrate formultiple treatments. The method includes using a controller of theproportioning machine, flowing purified water from the water source andconcentrate from the one or more containers through the fluid circuit tothe mixing container to prepare a dialysis fluid in the mixing containerby proportioning the water and concentrate. The flowing includes flowingwater and concentrate through at least one sterilizing filter to ensuresterility of the water and concentrate. The at least one sterilizingfilter includes serially-connected redundant sterilizing filters or themethod including, using the controller, testing the integrity of amembrane of the at least one sterilizing filter and preventing a use ofcontents of the mixing container responsively to a result of thetesting. The method includes using the controller, treating a patientusing the dialysis fluid from the mixing container, the treatingincluding performing multiple fill and drain cycles of a peritonealdialysis treatment. The method includes replacing the fluid circuit witha new fluid circuit. The method includes repeating the connecting afluid circuit, flowing purified water and concentrate, and repeating thetreating a patient, without replacing the one or more fresh containersof concentrate, whereby the one or more fresh concentrate containers arereplaced once every multiple treatments.

In variations thereof, the thirteenth embodiments include ones in whichthe at least one filter is integrally attached to the fluid circuit. Invariations thereof, the thirteenth embodiments include ones in which theflowing water and concentrate through at least one sterilizing filterincludes flowing water and concentrate through separate filters. Invariations thereof, the thirteenth embodiments include ones in which theat least one filter includes a testable filter with an air line, themethod including, using the controller, applying a pressure to the airline to test an ability of a wetted membrane of the testable filter towithstand pressure and thereby indicate the membrane's integrity. Invariations thereof, the thirteenth embodiments include ones in which theconnecting a water source and one or more containers of concentrate tothe fluid circuit includes: at a first time, replacing one or more spentcontainers of concentrate with the one or more fresh containers ofconcentrate; at a second time, connecting a fluid inlet line of thefluid circuit with the at least one sterilizing filter to a common fluidoutlet of a fluid source module; the fluid source module havingautomatic valves connected to a water source and the one or more freshcontainers of concentrate, the automatic valves selecting, under controlof the controller, only one of the water source and the one or morefresh containers of concentrate for connection to the fluid inlet lineat a given time.

In variations thereof, the thirteenth embodiments include ones in whichthe flowing water and concentrate includes pumping the water andconcentrate by the fluid source module.

According to fourteenth embodiments, the disclosed subject matterincludes treatment method including connecting a fluid circuit to aproportioning machine, the fluid circuit including a mixing container.The proportioning machine has actuators that engage with the fluidcircuit when received thereby. The method includes connecting one ormore containers of medicament concentrate to the fluid circuit, eachcontainer having sufficient medicament concentrate for multipletreatments. The method includes using the proportioning machine, flowingpurified water and concentrate through the fluid circuit to the mixingcontainer to prepare a medicament in the mixing container byproportioning the purified water and medicament concentrate. The flowingincludes flowing water and concentrate through at least one sterilizingfilter to ensure sterility of the water and concentrate. The methodincludes ensuring an integrity of the at least one sterilizing filter bytesting the at least one sterilizing filter or providingserially-connected redundant sterilizing filters. The method includestreating a patient using the prepared medicament in the mixingcontainer. The method includes replacing the fluid circuit with a newfluid circuit and repeating the connecting a fluid circuit, flowingpurified water and concentrate, treating a patient, without replacingthe one or more containers of medicament concentrate.

In variations thereof, the fourteenth embodiments include ones in whichthe at least one filter is integrally attached to the fluid circuit. Invariations thereof, the fourteenth embodiments include ones in which theflowing water and concentrate through at least one sterilizing filterincludes flowing water and concentrate through separate filters.

According to fifteenth embodiments, the disclosed subject matterincludes a system for preparation of sterile medical treatment fluid.The system includes t least one fluid circuit with a pumping tubesegment and multiple valve segments, at least one pumping actuator, andmultiple valve actuators positioned to engage the multiple valvesegments. The at least one pumping actuator engages the at least onepumping tube segment. A controller is connected to control the multiplevalve actuators and the at least one pumping actuator. A first of themultiple valve segments is along a fluid inlet line with a sterilizingfilter. A first multi-treatment concentrate container has sufficientconcentrate for preparation of enough peritoneal dialysis fluid toperform multiple peritoneal dialysis treatments, each treatmentincluding multiple fill/drain cycles. The system has a water source. Theat least one fluid circuit has, integrally-attached thereto, a firstsingle-treatment concentrate container and a mixing container, themixing container being sized to hold sufficient peritoneal dialysisfluid for at least a single fill cycle. Ones of the multiple valvesegments is/are connected between the fluid inlet line and the watersource and between the first multi-treatment concentrate container andthe fluid inlet line. The controller, controlling the ones of themultiple valve segments and the at least one pumping actuator,sequentially connects the first single-treatment concentrate containerand the water source to the fluid inlet line and controls flow such thatwater is conveyed from the water source to the mixing container andconcentrate is conveyed from the first multi-treatment concentratecontainer to the first single-treatment concentrate container, andsubsequently incorporated in a dialysis fluid formed in the mixingcontainer.

In variations thereof, the fifteenth embodiments include ones in whichthe controller is configured to perform a fill/drain cycle includingdraining spent fluid from a patient line and pumping the dialysis fluidfrom the mixing container to the patient line. In variations thereof,the fifteenth embodiments include ones that include a secondmulti-treatment concentrate container, wherein, ones of the multiplevalve segments are connected the second multi-treatment concentratecontainer and the fluid inlet line. In variations thereof, the fifteenthembodiments include ones that include a second single-treatmentconcentrate container connected to the fluid circuit, the controllertransferring concentrate from the second multi-treatment concentratecontainer to the second single-treatment concentrate container to formthe dialysis fluid. In variations thereof, the fifteenth embodimentsinclude ones in which the sterilizing filter has an air port to allow amembrane of the sterilizing filter to be pressure tested, the controllerbeing programmed to test the sterilizing filter membrane by applyingpressure to the air port and measuring the pressure after pumping watertherethrough. In variations thereof, the fifteenth embodiments includeones in which controller generates an alarm signal responsively to aresult of a test of the sterilizing filter membrane if the testindicates a loss of integrity of the sterilizing filter membrane.

According to sixteenth embodiments, the disclosed subject matterincludes fluid circuit for dialysis solution preparation. A valvenetwork has interconnected channels that can be opened and closed byopening and closing valve portions of the interconnected channels. Afluid inlet line has an inline sterilizing filter, a mixing container, afirst concentrate container, a drain line, a patient fill/drain line allempty and pre-connected to the valve network to form a unit and sealedfrom an external environment. The valve network has a pumping portion topump fluid between the interconnected channels.

In variations thereof, the sixteenth embodiments include ones in whichthe patient fill/drain line includes separate branch lines that connectto the valve network which branch lines merge to form a single line thatconnects to a patient. In variations thereof, the sixteenth embodimentsinclude ones in which the inline sterilizing filter has an air lineattached thereto, the air line being connected such that air forcedthrough the air line applies pressure to a membrane of the inlinesterilizing filter to permit an integrity test thereof. In variationsthereof, the sixteenth embodiments include ones in which the valvenetwork is attached to a rigid manifold member, the air line beingconnecting to a port fixedly attached to the rigid manifold member. Invariations thereof, the sixteenth embodiments include ones in which theair line is collinear with the fluid inlet line. In variations thereof,the sixteenth embodiments include ones in which valve network issupported by a panel. In variations thereof, the sixteenth embodimentsinclude ones in which the valve network is supported by a panel, thepumping portion being supported by a rigid manifold portion of the valvenetwork which is spaced from the panel. In variations thereof, thesixteenth embodiments include ones in which the rigid manifold portionhas pressure sensing diaphragms integrated in and supported thereby.

In variations thereof, the sixteenth embodiments include ones in whichthe air line is integral with at least a portion of the fluid inletline. In variations thereof, the sixteenth embodiments include ones inwhich the rigid manifold portion pressure sensing diaphragms are locatedone at each end of the pumping portion. In variations thereof, thesixteenth embodiments include ones in which the pumping portion isstraight. In variations thereof, the sixteenth embodiments include onesthat include a second concentrate container pre-connected to the valvenetwork. In variations thereof, the sixteenth embodiments include onesin which the mixing container and first and second concentratecontainers are polymer bags. In variations thereof, the sixteenthembodiments include ones in which the mixing container has a largerinternal volume than the first and second concentrate containers. Invariations thereof, the sixteenth embodiments include ones in which thepanel has windows that overlie the valve portions. In variationsthereof, the sixteenth embodiments include ones in which the valvenetwork includes a manifold portion with a pumping tube segment. Invariations thereof, the sixteenth embodiments include ones in which thevalve portions are portions of a bank of tubes stemming from themanifold portion. In variations thereof, the sixteenth embodimentsinclude ones in which the valve portions are portions of a bank ofparallel tubes stemming from the manifold portion. In variationsthereof, the sixteenth embodiments include ones that include a secondsterilizing filter connected in series with the inline sterilizingfilter such that the second and inline sterilizing filters are separatedby a flow channel. In variations thereof, the sixteenth embodimentsinclude ones in which the mixing container and first concentratecontainer are defined by two bonded flexible panels along seams todefine the mixing container and concentrate container. In variationsthereof, the sixteenth embodiments include ones in which the valvenetwork fluidly interconnects the fluid inlet line to the concentratecontainer. In variations thereof, the sixteenth embodiments include onesin which the valve network fluidly interconnects the concentratecontainer with the mixing container. In variations thereof, thesixteenth embodiments include ones in which the valve network fluidlyinterconnects the mixing container with the patient fill and patientdrain lines.

According to seventeenth embodiments, the disclosed subject matterincludes system for performing a peritoneal dialysis treatment. At leasttwo multi-treatment concentrate containers have concentrate supplyconnectors, the at least two multi-treatment concentrate containershaving sufficient concentrate to perform multiple dialysis treatments,where each treatment includes multiple fill/drain cycles. A valvenetwork has interconnected channels that can be opened and closed byopening and closing valve portions of the interconnected channels. Afluid inlet line has an inline sterilizing filter, a mixing container,first and second single-treatment concentrate containers, a drain line,a patient fill/drain line all empty and pre-connected to the valvenetwork to form a unit and sealed from an external environment. Thevalve network has a pumping portion to pump fluid between theinterconnected channels.

In variations thereof, the seventeenth embodiments include ones thatinclude a connection platform that mechanically supports the at leasttwo multi-treatment concentrate containers and selectively couples themto the fluid inlet line. In variations thereof, the seventeenthembodiments include ones that include a connection platform with a watersource and attachments for the at least two multi-treatment concentratecontainers, the connection platform having a valve system that fluidlycouples the at least two multi-treatment concentrate containers and thewater source to the fluid inlet line. In variations thereof, theseventeenth embodiments include ones in which the inline sterilizingfilter has an air line attached thereto, the air line being connectedsuch that air forced through the air line applies pressure to a membraneof the inline sterilizing filter to permit an integrity test thereof. Invariations thereof, the seventeenth embodiments include ones in whichthe air lines are each collinear with at least a portion of the fluidinlet line. In variations thereof, the seventeenth embodiments includeones in which the air lines are each attached along at least a portionof the fluid inlet line. In variations thereof, the seventeenthembodiments include ones in which the valve network is supported by apanel, the pumping portion being supported by a rigid manifold portionof the valve network which is spaced from the panel. In variationsthereof, the seventeenth embodiments include ones in which the manifoldportion has pressure sensors integrated therein, one at each end of apumping tube segment of the pumping portion. In variations thereof, theseventeenth embodiments include ones in which the pumping tube segmentis straight. In variations thereof, the seventeenth embodiments includeones in which the pressure sensor includes a pressure pod with adiaphragm that serves as a portion of a wall of a respective one of twoseparate chambers of the rigid manifold portion. In variations thereof,the seventeenth embodiments include ones in which the valve network isattached to a rigid manifold, the air line being connecting to a portfixedly attached to the rigid manifold. In variations thereof, theseventeenth embodiments include ones in which the air line is collinearwith the fluid inlet line. In variations thereof, the seventeenthembodiments include ones in which the valve network is supported by apanel. In variations thereof, the seventeenth embodiments include onesthat include a second concentrate container pre-connected to the valvenetwork.

In variations thereof, the seventeenth embodiments include ones in whichthe mixing container and first and second concentrate containers arepolymer bags. In variations thereof, the seventeenth embodiments includeones in which the mixing container has a larger internal volume than thefirst and second single-treatment concentrate containers. In variationsthereof, the seventeenth embodiments include ones in which the panel haswindows that overlie the valve portions. In variations thereof, theseventeenth embodiments include ones in which the valve network includesa manifold portion with a pumping tube segment. In variations thereof,the seventeenth embodiments include ones in which the valve portions areportions of a bank of tubes stemming from the manifold. In variationsthereof, the seventeenth embodiments include ones in which the valveportions are portions of a bank of parallel tubes stemming from themanifold. In variations thereof, the seventeenth embodiments includeones that include a second sterilizing filter connected in series withthe inline sterilizing filter such that the second and inlinesterilizing filters are separated by a flow channel.

In variations thereof, the seventeenth embodiments include ones in whichthe mixing container and first and second single-treatment concentratecontainers are defined by two bonded flexible panels along seams todefine the mixing container and first and second single-treatmentconcentrate containers. In variations thereof, the seventeenthembodiments include ones in which the valve network fluidlyinterconnects the fluid inlet line to the first and secondsingle-treatment concentrate containers. In variations thereof, theseventeenth embodiments include ones in which the valve network fluidlyinterconnects the first and second single-treatment concentratecontainers with the mixing container. In variations thereof, theseventeenth embodiments include ones in which the valve network fluidlyinterconnects the mixing container with the patient fill/drain line. Invariations thereof, the seventeenth embodiments include ones in whichthe at least two multi-treatment concentrate containers are contained ina single package. In variations thereof, the seventeenth embodimentsinclude ones in which the single package is housed by a single box. Invariations thereof, the seventeenth embodiments include ones thatinclude a connection platform with a water source and attachments forthe at least two multi-treatment concentrate containers, the connectionplatform fluidly coupling the at least two multi-treatment concentratecontainers and the water source to the fluid inlet line using controlvalves that include one for each of the at least two multi-treatmentconcentrates containers and one the water source, the water sourcehaving a water pump. In variations thereof, the seventeenth embodimentsinclude ones that include a connection platform with a water source andattachments for the at least two multi-treatment concentrate containers,the connection platform fluidly coupling the at least twomulti-treatment concentrate containers and the water source to the fluidinlet line using control valves that include one for each of the atleast two concentrates and one the water source, the at least twoconcentrates containers connecting to a common line having a concentratepump. In variations thereof, the seventeenth embodiments include onesthat include a connection platform with a water source and attachmentsfor the at least two multi-treatment concentrate containers, theconnection platform fluidly coupling the at least two multi-treatmentconcentrate containers and the water source to the fluid inlet lineusing control valves that include one for each of the at least twoconcentrates and one the water source, and the water source having apump, the at least two concentrates containers connecting to a commonline having a concentrate pump.

In variations thereof, the seventeenth embodiments include ones thatinclude a controller programmed to control the connection platformcontrols valves to connect the at least two multi-treatment concentratecontainers sequentially to the fluid inlet line to fill the at least twomulti-treatment concentrate containers with concentrate. In variationsthereof, the seventeenth embodiments include ones in which thecontroller controls the connection platform water pump to convey waterto the mixing container through the fluid inlet line. In variationsthereof, the seventeenth embodiments include ones that include acontroller programmed to control the connection platform control valvesand the concentrate pump to connect the at least two multi-treatmentconcentrate containers sequentially to the fluid inlet line to fill thefirst and second single-treatment concentrate containers withconcentrate. In variations thereof, the seventeenth embodiments includeones in which the controller controls the connection platform water pumpto convey water to the mixing container through the fluid inlet line. Invariations thereof, the seventeenth embodiments include ones thatinclude a controller programmed to control the connection platformcontrol valves and the concentrate pump to connect the at least twomulti-treatment concentrate containers sequentially to the fluid inletline to fill the first and second single-treatment concentratecontainers with concentrate and to control the connection platformcontrol valves and the connection platform water pump to fill the mixingcontainer with water.

According to eighteenth embodiments, the disclosed subject matterincludes system for performing peritoneal dialysis. A peritonealdialysis cycler has a fluid circuit with a fluid inlet, a mixingcontainer, and at least two concentrate containers. The peritonealdialysis cycler has actuators to pump and direct concentrate and waterselectively through the fluid circuit to transfer concentrate from anexternal source, through the fluid inlet, to the at least twoconcentrate containers, to transfer water through the fluid inlet to themixing container, and to transfer concentrate from the at least twoconcentrate containers to the mixing container to form dialysis fluid.The peritoneal dialysis cycler actuators also transferring dialysisfluid to a patient line.

In variations thereof, the eighteenth embodiments include ones in whichthe at least two concentrate containers are empty. 203. In variationsthereof, the eighteenth embodiments include ones that include aprogrammable controller that controls the actuators. In variationsthereof, the eighteenth embodiments include ones in which the actuatorsinclude pumping and valve actuators. In variations thereof, theeighteenth embodiments include ones in which the fluid circuit includesvalve segments that are pinched by the valve actuators. In variationsthereof, the eighteenth embodiments include ones in which the fluidinlet has an inline sterilizing filter. In variations thereof, theeighteenth embodiments include ones in which the inline sterilizingfilter includes two filters or a single testable filter having an airline for applying air pressure to a membrane thereof. In variationsthereof, the eighteenth embodiments include ones that include a fluidsource module with input connections for concentrate and water and anoutlet connection connectable to the fluid inlet. In variations thereof,the eighteenth embodiments include ones in which the fluid source modulehas actuators that sequentially connect concentrate and water to theoutlet connection. In variations thereof, the eighteenth embodimentsinclude ones in which the peritoneal dialysis cycler controls the fluidsource module actuators. In variations thereof, the eighteenthembodiments include ones in which the fluid source module actuatorsinclude valve and pump actuators. In variations thereof, the eighteenthembodiments include ones in which the fluid source pump actuatorsinclude a water pump that pumps water through a filter system togenerate purified water flowing through a purified water supply lineconnected to the outlet connection and the fluid source module valveactuators include a water valve actuator that selectively closes andopens the purified water supply line. In variations thereof, theeighteenth embodiments include ones in which the fluid source pumpactuators include a concentrate pump that pumps concentrate fromconcentrate containers connected through respective concentrate feedlines to a common concentrate line that connect to the outletconnection, the fluid source module valve actuators includingconcentrate valve actuators that selectively close and open therespective concentrate feed lines. In variations thereof, the eighteenthembodiments include ones in which the peritoneal dialysis cycler has aprogrammable controller that controls the peritoneal dialysis cycleractuators.

In variations thereof, the eighteenth embodiments include ones in whichthe fluid source module pump actuators include a water pump, controlledby the programmable controller, that pumps water through a filter systemto generate purified water flowing through a purified water supply lineconnected to the outlet connection and the fluid source module valveactuators include a water valve actuator that selectively closes andopens the purified water supply line under control of the programmablecontroller. In variations thereof, the eighteenth embodiments includeones in which the fluid source module pump actuators include aconcentrate pump, controlled by the programmable controller, that pumpsconcentrate from concentrate containers connected through respectiveconcentrate feed lines to a common concentrate line that connect to theoutlet connection, the fluid source module valve actuators includingconcentrate valve actuators that selectively close and open therespective concentrate feed lines under the control of the programmablecontroller.

In variations thereof, the eighteenth embodiments include ones in whichthe fluid source module pump actuators include a concentrate pump,controlled by the programmable controller, that pumps concentrate fromconcentrate containers connected through respective concentrate feedlines to a common concentrate line that connect to the outletconnection, the fluid source module valve actuators includingconcentrate valve actuators that selectively close and open therespective concentrate feed lines under the control of the programmablecontroller and wherein the fluid source pump actuators include a waterpump, controlled by the programmable controller, that pumps waterthrough a filter system to generate purified water flowing through apurified water supply line connected to the outlet connection and thefluid source module valve actuators include a water valve actuator thatselectively closes and opens the purified water supply line under thecontrol of the programmable controller.

According to nineteenth embodiments, the disclosed subject matterincludes fluid system for peritoneal dialysis and dialysis solutionpreparation. A pre-connected fluid circuit has a disposable mixingcontainer of polymeric material, an empty concentrate container ofpolymeric material, a fluid multiplexer that includes a valve networkthat has junctions and valve portions that mechanically interface withvalve actuators to define selectable flow paths in the valve network.The valve network further includes a concentrate line connected to theconcentrate container, a fluid inlet line terminated by a fluid inletline connector, and a pair of lines connected to the mixing container topermit simultaneous flow into, and flow out from, the mixing container.The fluid circuit is preconnected and sealed as a unit to isolate aninternal volume thereof from an external environment to preservesterility. An actuator device has valve actuators, sensors, and apumping actuator. The fluid circuit has sensor and pumping portions thatengage, respectively, along with the valve portions, with effecters ofthe actuator device.

In variations thereof, the nineteenth embodiments include ones in whichthe fluid inlet line has an inline sterilizing filter with an air lineattached thereto, the air line being connected such that air forcedthrough the air line applies pressure to a membrane of the inlinesterilizing filter to permit an integrity test thereof. In variationsthereof, the nineteenth embodiments include ones in which the fluidinlet line has respective sterilizing filters serially-connectedsterilizing filter elements. In variations thereof, the nineteenthembodiments include ones in which the valve network is positioned andheld in a cartridge that has a pumping portion supported by a rigidmanifold member, the manifold member being hollow and defining at leastsome of the junctions and the air line connecting to a port fixedlyattached to the manifold member. In variations thereof, the nineteenthembodiments include ones in which the valve network is in a cartridgewith the pumping portion held by a rigid manifold member thereof, themanifold member being hollow and defining at least some of thejunctions. In variations thereof, the nineteenth embodiments includeones in which the air line connects to a port fixedly attached to themanifold member. In variations thereof, the nineteenth embodimentsinclude ones in which the manifold member is rigid and has two separatechambers connected by the pumping portion.

In variations thereof, the nineteenth embodiments include ones in whichthe valve network is supported by a panel providing support for thecartridge, the manifold member being connected to the panel. Invariations thereof, the nineteenth embodiments include ones in which thevalve network is supported by a panel, the manifold member being spacedapart from the panel. In variations thereof, the nineteenth embodimentsinclude ones in which at least one of the two separate chambers haspressure sensors integrated therein, one at each end of the pumpingportion. In variations thereof, the nineteenth embodiments include onesin which the pressure sensor includes a pressure pod with a diaphragmthat serves as a portion of a wall of a respective one of the twoseparate chambers. In variations thereof, the nineteenth embodimentsinclude ones in which the respective concentrate line connectors areconnected by a frame that support a portion of the concentrate line. Invariations thereof, the nineteenth embodiments include ones in whichframe has a window and the portion of the concentrate line passes acrossthe window. In variations thereof, the nineteenth embodiments includeones in which valve network has a drain line. In variations thereof, thenineteenth embodiments include ones in which valve network has adialysis solution fill/drain line connectable to a peritoneal catheter.In variations thereof, the nineteenth embodiments include ones in whichfill/drain line is sealed by a removable end cap. In variations thereof,the nineteenth embodiments include ones in which the dialysis solutionfill/drain line has a second air line collinear with the dialysissolution fill/drain line, connected at an end of the dialysis solutionfill/drain line to a pressure pod connected to the dialysis solutionfill/drain line to measure a pressure therewithin. In variationsthereof, the nineteenth embodiments include ones in which drain andfluid inlet lines are connected by a frame that support portions of thedrain and fluid inlet lines. In variations thereof, the nineteenthembodiments include ones in which frame has a window and portions of thedrain and fluid inlet lines pass across the window. In variationsthereof, the nineteenth embodiments include ones in which the valveportions are supported by a planar element. In variations thereof, thenineteenth embodiments include ones in which planar element includes apair of sheets shaped to hold the valve portions in predefinedpositions. In variations thereof, the nineteenth embodiments includeones in which the planar element includes a pair of sheets shaped tohold the valve portions in predefined positions, at least one of thepair of sheets having holes in it to permit valve actuators to contactthe valve portions. In variations thereof, the nineteenth embodimentsinclude ones in which the valve portions are tube segments. Invariations thereof, the nineteenth embodiments include ones in which thevalve portions are tube segments. In variations thereof, the nineteenthembodiments include ones in which the concentrate line is sealed by afrangible seal. In variations thereof, the nineteenth embodimentsinclude ones in which the mixing container and concentrate container aredefined by two bonded flexible panels along seams to define the mixingcontainer and concentrate container. In variations thereof, thenineteenth embodiments include ones in which the seams are a result ofthermal welding. In variations thereof, the nineteenth embodimentsinclude ones in which the fluid circuit encloses a sterile internalvolume. In variations thereof, the nineteenth embodiments include onesin which the actuator device includes a peritoneal dialysis cycler.

According to twentieth embodiments, the disclosed subject matterincludes a system for administering a peritoneal dialysis treatment. Aperitoneal dialysis system component is connectable to one or morelong-term containers of dialysis fluid concentrate and a water source. Adisposable fluid circuit has a pumping portion, a mixing container, andone or more short-term concentrate containers. Pumping and valveactuators are controlled by a controller, which controls them to engagethe disposable fluid circuit to create a mixed batch of peritonealdialysis fluid by transferring sufficient concentrate for multiplecycles of a single treatment from the one or more long-term containersof dialysis fluid concentrate to the one or more short-term concentratecontainers and, for each cycle of a treatment, transferring sufficientconcentrate for a fill cycle from the one or more short-term concentratecontainers to the mixing container and transferring sufficient water toform a ready-to-use dialysate to the mixing container from the watersource.

In variations thereof, the twentieth embodiments include ones in whichthe mixing container and the short-term concentrate containers arepolymeric bags. In variations thereof, the twentieth embodiments includeones in which the pumping and valve actuators are controlled to performa fill cycle of an automated peritoneal dialysis treatment using thecontents of the mixing container. In variations thereof, the twentiethembodiments include ones that include at least one conductivity sensorconnected to a drain line of the fluid circuit, wherein the pumping andvalve actuators are controlled to sample contents of the mixingcontainer to obtain a conductivity measurement thereof.

According to twenty-first embodiments, the disclosed subject matterincludes a fluid circuit for peritoneal dialysis and dialysis solutionpreparation. A pre-connected fluid circuit has a disposable mixingcontainer of polymeric material, a concentrate container of polymericmaterial, a fluid multiplexer that includes a valve network that hasjunctions and valve portions that mechanically interface with valveactuators to define selectable flow paths in the valve network. Thevalve network further includes a concentrate line connected to theconcentrate container, a fluid inlet line terminated by a fluid inletline connector, and a pair of lines connected to the mixing container topermit simultaneous flow into, and flow out from, the mixing container.The fluid inlet line has an inline sterilizing filter. The valve networkis positioned and held in a cartridge that has a pumping portionsupported by a manifold member, the manifold member being hollow anddefining at least some of the junctions. The fluid circuit ispreconnected and sealed as a unit to isolate an internal volume thereoffrom an external environment to preserve sterility.

In variations thereof, the twenty-first embodiments include ones inwhich the manifold member is rigid and defines two separate chambersconnected by the pumping portion. In variations thereof, thetwenty-first embodiments include ones in which fluid inlet line has anair line that is collinear with the fluid inlet line and connects to theinline sterilizing filter. In variations thereof, the twenty-firstembodiments include ones in which the valve network is supported by apanel, the manifold member being connected to the panel. In variationsthereof, the twenty-first embodiments include ones in which the valvenetwork is supported by a panel, the manifold member being spaced apartfrom the panel. In variations thereof, the twenty-first embodimentsinclude ones in which the manifold has pressure sensors integratedtherein, one at each end of a pumping tube segment. In variationsthereof, the twenty-first embodiments include ones in which the pumpingtube segment is straight. In variations thereof, the twenty-firstembodiments include ones in which the pressure sensors include apressure pod with a diaphragm that serves as a portion of a wall of arespective one of the two separate chambers. In variations thereof, thetwenty-first embodiments include ones in which the valve network has adrain line. In variations thereof, the twenty-first embodiments includeones in which the drain and fluid lines are connected by a frame thatsupport portions of the drain and fluid lines. In variations thereof,the twenty-first embodiments include ones in which the frame has awindow and the portion of the drain and fluid lines passes across thewindow. In variations thereof, the twenty-first embodiments include onesin which the valve network has a dialysis solution fill/drain lineconnectable to a peritoneal catheter. In variations thereof, thetwenty-first embodiments include ones in which the fill/drain line issealed by a removable end cap. In variations thereof, the twenty-firstembodiments include ones in which the valve network has a dialysissolution fill/drain line connectable to a peritoneal catheter and thedialysis solution fill/drain line has a second air line collinear withthe dialysis solution fill/drain line, connected at an end of thedialysis solution fill/drain line to a pressure pod connected to thedialysis solution fill/drain line to measure a pressure therewithin. Invariations thereof, the twenty-first embodiments include ones in whichthe drain and fluid inlet lines are connected by a frame that supportportions of the drain and fluid inlet lines. In variations thereof, thetwenty-first embodiments include ones in which the frame has a windowand portions of the drain and fluid inlet lines pass across the window.In variations thereof, the twenty-first embodiments include ones inwhich the valve portions are supported by a planar element. Invariations thereof, the twenty-first embodiments include ones in whichthe planar element includes a pair of sheets shaped to hold the valveportions in predefined positions. In variations thereof, thetwenty-first embodiments include ones in which the planar elementincludes a pair of sheets shaped to hold the valve portions inpredefined positions, at least one of the pair of sheets having holes init to permit valve actuators to contact the valve portions. Invariations thereof, the twenty-first embodiments include ones in whichthe valve portions are tube segments. In variations thereof, thetwenty-first embodiments include ones in which the valve portions aretube segments. In variations thereof, the twenty-first embodimentsinclude ones in which the mixing container and concentrate container aredefined by two bonded flexible panels along seams to define the mixingcontainer and concentrate container. In variations thereof, thetwenty-first embodiments include ones in which the seams are a result ofthermal welding. In variations thereof, the twenty-first embodimentsinclude ones in which the fluid circuit encloses a sterile internalvolume.

According to twenty-second embodiments, the disclosed subject matterincludes a fluid circuit for peritoneal dialysis and dialysatepreparation. A disposable mixing container of polymeric material has apre-attached fluid circuit, the mixing container and fluid circuit beingsealed from an external environment. A concentrate container ofpolymeric material is pre-attached to the fluid circuit, the concentratecontainer being sealed from an external environment. The fluid circuitincludes a fluid multiplexer that includes a valve network that hasjunctions and valve portions that mechanically interface with valveactuators to define selectable flow paths in the valve network. Thevalve network further including a concentrate line connected to theconcentrate container, a water line terminated by a water lineconnector, and a at least one mixing container line connected to themixing container to permit simultaneous flow into, and flow out from,the mixing container. The water line has an inline sterilizing filter.The valve network is positioned and held in a cartridge that has apumping portion supported by a manifold member, the manifold memberbeing hollow and defining at least some of the junctions. The manifoldmember defines two separate chambers connected by a pumping tubesegment.

In variations thereof, the twenty-second embodiments include ones inwhich the water line has an air line attached thereto, the air linebeing connected such that air forced through the air line appliespressure to a membrane of the inline sterilizing filter to permit anintegrity test thereof. In variations thereof, the twenty-secondembodiments include ones in which the valve network is supported by apanel, the manifold member being connected to the panel. In variationsthereof, the twenty-second embodiments include ones in which the valvenetwork is supported by a panel, the manifold member being spaced apartfrom the panel. In variations thereof, the twenty-second embodimentsinclude ones in which the air line is integral with at least a portionof a respective one of the concentrate and water lines. In variationsthereof, the twenty-second embodiments include ones in which themanifold has pressure sensors integrated therein, one at each end of thepumping portion. In variations thereof, the twenty-second embodimentsinclude ones in which the pumping portion is straight. In variationsthereof, the twenty-second embodiments include ones in which thepressure sensor includes a pressure pod with a diaphragm that serves asa portion of a wall of a respective one of the two separate chambers. Invariations thereof, the twenty-second embodiments include ones in whichthe valve network has a drain line and the respective water and drainlines are connected by a frame that support portions thereof. Invariations thereof, the twenty-second embodiments include ones in whichthe frame has a window and the portions pass across the window. Invariations thereof, the twenty-second embodiments include ones in whichthe valve network has a drain line. In variations thereof, thetwenty-second embodiments include ones in which the valve network has adialysate fill/drain line connectable to a peritoneal catheter. Invariations thereof, the twenty-second embodiments include ones in whichthe fill/drain line is sealed by a removable end cap. In variationsthereof, the twenty-second embodiments include ones in which the valvenetwork has a dialysate fill/drain line connectable to a peritonealcatheter and wherein the dialysate fill/drain line has a second air linecollinear with the dialysate fill/drain line, connected at an end of thedialysate fill/drain line to a pressure pod connected to the dialysatefill/drain line to measure a pressure therewithin. In variationsthereof, the twenty-second embodiments include ones in which the drainand water lines are connected by a frame that support portions of thedrain and water lines. In variations thereof, the twenty-secondembodiments include ones in which the frame has a window and portions ofthe drain and water lines pass across the window. In variations thereof,the twenty-second embodiments include ones in which the valve portionsare supported by a planar element. In variations thereof, thetwenty-second embodiments include ones in which the planar elementincludes a pair of sheets shaped to hold the valve portions inpredefined positions. In variations thereof, the twenty-secondembodiments include ones in which the planar element includes a pair ofsheets shaped to hold the valve portions in predefined positions, atleast one of the pair of sheets having holes in it to permit valveactuators to contact the valve portions.

In variations thereof, the twenty-second embodiments include ones inwhich the valve portions are tube segments. In variations thereof, thetwenty-second embodiments include ones in which the valve portions aretube segments. In variations thereof, the twenty-second embodimentsinclude ones in which the concentrate line is sealed by a frangibleseal. In variations thereof, the twenty-second embodiments include onesin which the cartridge includes parallel panels with the valve networksandwiched between them, the frangible seal held in the cartridgealigned with windows in at least one of the panels to permit an actuatorto fracture them prior to use thereby allowing the concentrate to flowthrough the concentrate line. In variations thereof, the twenty-secondembodiments include ones in which the cartridge includes a single foldedpanel forming parallel panel portions with the valve network sandwichedbetween them, the frangible seal being held in the cartridge alignedwith windows in at least one of the panels to permit an actuator tofracture them prior to use thereby allowing the concentrate to flowthrough the concentrate line. In variations thereof, the twenty-secondembodiments include ones in which the valve network includes theconcentrate line which is sealed by a frangible seal thereby separatingthe concentrate from the rest of the fluid circuit until the frangibleseal is fractured. In variations thereof, the twenty-second embodimentsinclude ones that include a second sterilizing filter connected inseries with the inline sterilizing filter such that the second andinline sterilizing filters are separated by a flow channel to preventgrow-through contamination between membranes thereof. In variationsthereof, the twenty-second embodiments include ones in which the mixingcontainer and concentrate container are defined by two bonded flexiblepanels along seams to define the mixing container and concentratecontainer. In variations thereof, the twenty-second embodiments includeones in which seams are a result of thermal welding. In variationsthereof, the twenty-second embodiments include ones in which the fluidcircuit encloses a sterile internal volume.

According to twenty-third embodiments, the disclosed subject matterincludes a fluid system for peritoneal dialysis and dialysatepreparation. A disposable mixing container of polymeric material has apre-attached fluid circuit, the mixing container and fluid circuit beingsealed from an external environment. A concentrate container ofpolymeric material is pre-attached to the fluid circuit, the concentratecontainer being sealed from an external environment. The fluid circuitincludes a fluid multiplexer that includes a valve network that hasjunctions and valve portions that mechanically interface with valveactuators to define selectable flow paths in the valve network. Thevalve network further includes a concentrate line connected to theconcentrate container, a water line terminated by a water lineconnector, and a pair of lines connected to the mixing container topermit simultaneous flow into, and flow out from, the mixing container.The water line has an inline sterilizing filter with an air lineattached thereto, the air line being connected such that air forcedthrough the air line applies pressure to a membrane of the inlinesterilizing filter to permit an integrity test thereof. An actuatordevice has valve actuators, sensors, and a pumping actuator. The fluidcircuit has sensor and pumping portions that engage, respectively, alongwith the valve portions, with effecters of the actuator device.

In variations thereof, the twenty-third embodiments include ones inwhich the valve network is in a cartridge with the pumping portion heldby a rigid manifold member thereof, the manifold member being hollow anddefining at least some of the junctions. In variations thereof, thetwenty-third embodiments include ones in which the air line connects toa port fixedly attached to the manifold member. In variations thereof,the twenty-third embodiments include ones in which the manifold memberis rigid and has two separate chambers connected by the pumping portion.In variations thereof, the twenty-third embodiments include ones inwhich the valve network is supported by a panel providing support forthe cartridge, the manifold member being connected to the panel. Invariations thereof, the twenty-third embodiments include ones in whichthe valve network is supported by a panel, the manifold member beingspaced apart from the panel. In variations thereof, the twenty-thirdembodiments include ones in which the manifold has pressure sensorsintegrated therein, one at each end of the pumping portion. Invariations thereof, the twenty-third embodiments include ones in whichpressure sensor includes a pressure pod with a diaphragm that serves asa portion of a wall of a respective one of the two separate chambers. Invariations thereof, the twenty-third embodiments include ones in whichrespective concentrate line connectors are connected by a frame thatsupport a portion of the concentrate line. In variations thereof, thetwenty-third embodiments include ones in which frame has a window andthe portion of the concentrate line passes across the window. Invariations thereof, the twenty-third embodiments include ones in whichvalve network has a drain line.

In variations thereof, the twenty-third embodiments include ones inwhich valve network has a dialysate fill/drain line connectable to aperitoneal catheter. In variations thereof, the twenty-third embodimentsinclude ones in which fill/drain line is sealed by a removable end cap.In variations thereof, the twenty-third embodiments include ones inwhich dialysate fill/drain line has a second air line collinear with thedialysate fill/drain line, connected at an end of the dialysatefill/drain line to a pressure pod connected to the dialysate fill/drainline to measure a pressure therewithin. In variations thereof, thetwenty-third embodiments include ones in which drain and water linesconnected by a frame that support portions of the drain and water lines.In variations thereof, the twenty-third embodiments include ones inwhich In variations thereof, the twenty-third embodiments include onesin which frame has a window and portions of the drain and water linespass across the window. In variations thereof, the twenty-thirdembodiments include ones in which the valve portions are supported by aplanar element. In variations thereof, the twenty-third embodimentsinclude ones in which the planar element includes a pair of sheetsshaped to hold the valve portions in predefined positions. In variationsthereof, the twenty-third embodiments include ones in which planarelement includes a pair of sheets shaped to hold the valve portions inpredefined positions, at least one of the pair of sheets having holes init to permit valve actuators to contact the valve portions. Invariations thereof, the twenty-third embodiments include ones in whichthe valve portions are tube segments. In variations thereof, thetwenty-third embodiments include ones in which valve portions are tubesegments. In variations thereof, the twenty-third embodiments includeones in which the concentrate line is sealed by a frangible seal. Invariations thereof, the twenty-third embodiments include ones in whichthe cartridge includes parallel panels with the valve network sandwichedbetween them, the frangible seal held in the cartridge aligned withwindows in at least one of the panels to permit an actuator to fracturethem prior to use thereby allowing the concentrate to flow through theconcentrate line. In variations thereof, the twenty-third embodimentsinclude ones in which the cartridge includes a single folded panelforming parallel panel portions with the valve network sandwichedbetween them, the frangible seal being held in the cartridge alignedwith windows in at least one of the panels to permit an actuator tofracture them prior to use thereby allowing the concentrate to flowthrough the concentrate line. In variations thereof, the twenty-thirdembodiments include ones in which the valve network includes theconcentrate line which is sealed by a frangible seal thereby separatingthe concentrate from the rest of the fluid circuit until the frangibleseal is fractured. In variations thereof, the twenty-third embodimentsinclude ones that include a second sterilizing filter connected inseries with the inline sterilizing filter such that the second andinline sterilizing filters are separated by a flow channel to preventgrow-through contamination between membranes thereof. In variationsthereof, the twenty-third embodiments include ones in which the batchcontainer and concentrate container are defined by two bonded flexiblepanels along seams to define the batch container and concentratecontainer. In variations thereof, the twenty-third embodiments includeones in which the seams are a result of thermal welding. In variationsthereof, the twenty-third embodiments include ones in which the fluidcircuit encloses a sterile internal volume. In variations thereof, thetwenty-third embodiments include ones in which actuator device includesa peritoneal dialysis cycler. In variations thereof, the twenty-thirdembodiments include ones in which the drain and water lines connected bya frame that support portions of the drain and water lines and theactuator device has a cut-and-seal device and a receiving slot thatreceives the frame and aligns a windows of the frame with thecut-and-seal device. In variations thereof, the twenty-third embodimentsinclude ones in which the actuator device has a controller programmed toactivate the cut-and-seal device to cut and seal the concentrate linethereby permitting the fluid circuit to be separated from the frame anda concentrate line connector as well as a stub portion of theconcentrate line, which collectively remain in place on the actuatordevice to act as a seal on connectors of the actuator device.

According to twenty-fourth embodiments, the disclosed subject matterincludes a treatment method. The method includes using a peritonealcycler device with a fluid circuit having valve, container, and pumpingportions, the peritoneal cycler device having actuators and sensorscontrolled by a controller that interface with the valve and pumpingportions for preparing peritoneal dialysis fluid, and under control ofthe controller: accessing a priming bolus comprising a first volume of afirst fluid; priming at least a patient fill line with the primingbolus; preparing a treatment batch comprising a second volume of asecond fluid, wherein the second volume is larger than the first volume;and performing at least one fill/drain cycle of a renal replacementtherapy through the fluid circuit and using the treatment batch.

In variations thereof, the twenty-fourth embodiments include ones inwhich the accessing a priming bolus and the preparing a treatment batchboth include diluting and mixing at least one concentrate and thepreparing the accessing a priming bolus takes less time than thepreparing of the treatment batch. In variations thereof, thetwenty-fourth embodiments include ones that include, prior to thepreparing a treatment batch, determining that a fluid circuit isconnected to a patient and preventing the preparing a treatment batchuntil a fluid circuit is connected to a patient. In variations thereof,the twenty-fourth embodiments include ones in which the first fluid andthe second fluid have a same composition according to a sameprescription. In variations thereof, the twenty-fourth embodimentsinclude ones in which first fluid and the second fluid have differentcompositions. In variations thereof, the twenty-fourth embodimentsinclude ones in which first fluid is a non-prescription fluid. Invariations thereof, the twenty-fourth embodiments include ones in whichthe first fluid is water or saline.

In variations thereof, the twenty-fourth embodiments include ones thatinclude receiving by the controller an indication through a userinterface that quick priming is desired or determining whether a patientis full or empty and if not, skipping the accessing and the priming. Invariations thereof, the twenty-fourth embodiments include ones in whichthe priming bolus and the treatment batch are stored in a same mixingcontainer of the container portions. In variations thereof, thetwenty-fourth embodiments include ones in which at least one of thepriming bolus and the treatment batch is prepared by flowing purifiedwater and a medicament concentrate to the mixing container to proportionand dilute the medicament concentrate. In variations thereof, thetwenty-fourth embodiments include ones in which mixing container isdisposable. In variations thereof, the twenty-fourth embodiments includeones in which fluid circuit is disposable and includes a pumping tubesegment and multiple valve segments of the valve portions, whereinperitoneal cycler device includes at least one pumping actuatorpositioned to engage the pumping tube segment, wherein the peritonealcycler device further includes multiple valve actuators positioned toengage the valve segments. In variations thereof, the twenty-fourthembodiments include ones in which the preparing of the priming boluscomprises drawing a concentrate and water through a sterilizing filterin predefined quantities to make the first volume of the first fluid. Invariations thereof, the twenty-fourth embodiments include ones in whichthe preparing of the treatment batch comprises drawing a concentrate andwater through a sterilizing filter in predefined quantities to make thesecond volume of the second fluid, wherein the second fluid isperitoneal dialysis fluid, wherein the second volume provides asufficient quantity of peritoneal dialysis fluid for at least a singlefill of a treatment cycle.

In variations thereof, the twenty-fourth embodiments include ones inwhich the drawing includes, using an interconnection module, connectingwater and concentrate at different times to a common inlet of the fluidcircuit to which the sterilizing filter is integrally attached. Invariations thereof, the twenty-fourth embodiments include ones thatinclude testing the sterilizing filter by an air pressure test andusing, or preventing use of, the quantity for a peritoneal dialysis filland drain cycle depending on a result of the testing. In variationsthereof, the twenty-fourth embodiments include ones that includeconnecting a long-term concentrate container to the interconnectionmodule once every multiple peritoneal dialysis treatments. In variationsthereof, the twenty-fourth embodiments include ones in which the fluidcircuit, having a sterilizing filter integrally attached thereto, isconnected to the interconnection module once every single peritonealdialysis treatment.

According to twenty-fifth embodiments, the disclosed subject matterincludes a system for administering a peritoneal dialysis treatment. Aperitoneal dialysis cycler portion is connectable to a source of primingfluid. A controller, with a user interface, controls a fill/drain pumpof the peritoneal dialysis cycler portion. The controller requests inputthrough the user interface indicating whether a patient is full orempty. In response to the controller receiving input through the userinterface indicating the patient is empty, preparing a full batch ofperitoneal dialysis fluid prior to beginning a treatment. In response tothe controller receiving input through the user interface indicating thepatient is full, initiating a quick prime mode prior to beginning atreatment. The quick prime mode including preparing or accessing a quickprime bolus and using it to prime a patient line.

In variations thereof, the twenty-fifth embodiments include ones inwhich the quick prime bolus is of a different composition from aperitoneal dialysis fluid. In variations thereof, the twenty-fifthembodiments include ones in which the quick prime bolus is of water. Invariations thereof, the twenty-fifth embodiments include ones thatinclude, after the quick prime mode, using the controller, draining apatient. In variations thereof, the twenty-fifth embodiments includeones that include, in response to the controller receiving input throughthe user interface indicating the patient is empty, generating a commandto prevent access by a user to the quick prime mode.

According to twenty-sixth embodiments, the disclosed subject matterincludes a treatment method that includes preparing a priming batchcomprising a first volume of a first fluid and priming a patientfill/drain line with the priming batch. The method includes determiningthat a fluid circuit is connected to a patient. The method includespreparing a treatment batch comprising a second volume of a secondfluid, wherein the second volume is larger than the first volume. Themethod includes performing at least one fill/drain cycle of a renalreplacement therapy through the fluid circuit and using the treatmentbatch.

In variations thereof, the twenty-sixth embodiments include ones inwhich the preparing of the priming batch takes less time than thepreparing of the treatment batch. In variations thereof, thetwenty-sixth embodiments include ones in which the first fluid and thesecond fluid have a same composition according to a same prescription.In variations thereof, the twenty-sixth embodiments include ones inwhich first fluid and the second fluid have different compositions. Invariations thereof, the twenty-sixth embodiments include ones in whichthe first fluid is a non-prescription fluid. In variations thereof, thetwenty-sixth embodiments include ones in which the first fluid is wateror saline. In variations thereof, the twenty-sixth embodiments includeones in which the method is performed after receiving an indication fromthe patient to perform quick priming. In variations thereof, thetwenty-sixth embodiments include ones in which the priming batch and thetreatment batch are stored in a same mixing container. In variationsthereof, the twenty-sixth embodiments include ones in which at least oneof the priming batch and the treatment batch is prepared by flowingpurified water and a medicament concentrate to the mixing container toproportion and dilute the medicament concentrate.

In variations thereof, the twenty-sixth embodiments include ones inwhich the method is performed by a proportioning and treatment devicehaving actuators that engage with the fluid circuit when receivedthereby. In variations thereof, the twenty-sixth embodiments includeones in which the mixing container is disposable. In variations thereof,the twenty-sixth embodiments include ones in which the fluid circuit isdisposable and includes a pumping tube segment and multiple valvesegments, wherein the proportioning and treatment device includes atleast one pumping actuator positioned to engage the pumping tubesegment, wherein the proportioning and treatment device further includesmultiple valve actuators positioned to engage the valve segments. Invariations thereof, the twenty-sixth embodiments include ones in whichthe preparing of the priming batch comprises drawing a concentrate andwater through a sterilizing filter in predefined quantities to make thefirst volume of the first fluid. In variations thereof, the twenty-sixthembodiments include ones in which the preparing of the treatment batchcomprises drawing a concentrate and water through a sterilizing filterin predefined quantities to make the second volume of the second fluid,wherein the second fluid is peritoneal dialysate, wherein the secondvolume provides a sufficient quantity of peritoneal dialysate for asingle fill of a treatment cycle. In variations thereof, thetwenty-sixth embodiments include ones in which the drawing includes,using an interconnection module, connecting water and concentrate atdifferent times to a common inlet of the fluid circuit to which thesterilizing filter is integrally attached. In variations thereof, thetwenty-sixth embodiments include ones that that include testing thesterilizing filter by an air pressure test and using, or preventing useof, the quantity for a peritoneal dialysis fill and drain cycledepending on a result of the testing. In variations thereof, thetwenty-sixth embodiments include ones that include connecting along-term concentrate container to the interconnection module once everymultiple peritoneal dialysis treatments. In variations thereof, thetwenty-sixth embodiments include ones in which the fluid circuit havingthe sterilizing filter integrally attached thereto is connected to theinterconnection module once every single peritoneal dialysis treatment.

According to twenty-seventh embodiments, the disclosed subject matterincludes a system for preparation of sterile medical treatment fluidwith a disposable fluid circuit with a pumping tube segment and multiplevalve segments. A proportioning and treatment device with a pumpingactuator is shaped to engage the pumping tube segment and multiple valveactuators positioned to engage the valve segments. A first of themultiple valve segments is connected to a water inlet. A second of themultiple valve segments being connected to a first concentrate inlet.The disposable fluid circuit has a sterilizing filter connected betweeneach of the water inlet and the first concentrate inlet and respectiveones of the first and second of the multiple valve segments. A firstconcentrate container has sufficient concentrate for preparation ofenough peritoneal dialysate to perform multiple peritoneal dialysistreatments, each treatment including multiple fill/drain cycles. Thedisposable fluid circuit has a first concentrate inlet connector for thefirst concentrate inlet which is adapted to be connected to the firstconcentrate container. The disposable fluid circuit having anintegrally-attached mixing container sized to hold sufficient peritonealdialysate for at least a single fill/drain cycle. The proportioning andtreatment device has a programmable controller programmed to control thepumping actuator to pump concentrate and water into the mixing containerto make a batch of peritoneal dialysate and subsequently to perform afill/drain cycle including draining spent peritoneal dialysate andpumping a fill of the peritoneal dialysate from the mixing container.

In variations thereof, the twenty-seventh embodiments include ones inwhich the disposable fluid circuit has a second concentrate inlet with asterilizing filter connected between the second concentrate inlet and athird of the multiple valve segments. In variations thereof, thetwenty-seventh embodiments include ones that include a secondconcentrate container having concentrate for the preparation of enoughperitoneal dialysate to perform multiple peritoneal dialysis treatmentseach treatment including multiple fill/drain cycles, wherein the firstand second concentrate inlets are connected to the first and secondconcentrate containers by a double connector that carries the firstconcentrate inlet connector and a second concentrate inlet connector ofthe disposable fluid circuit, the double connector making connectionsfor the first concentrate inlet connector and the second concentrateinlet simultaneously to the first and second concentrate containers. Invariations thereof, the twenty-seventh embodiments include ones thatinclude an interconnection module that has a primary connector, to whichthe first concentrate container is connected once every multipletreatments, and a secondary connector to which the disposable fluidcircuit first concentrate inlet connector is connected once everytreatment. In variations thereof, the twenty-seventh embodiments includeones in which the water inlet has a sterilizing filter with an air portcontroller to allow a membrane of the sterilizing filter to be pressuretested such as by a bubble point test, the controller being programmedto test the sterilizing filter membrane by applying pressure to the airport controller and measuring the pressure after pumping watertherethrough. In variations thereof, the twenty-seventh embodimentsinclude ones in which the controller generates an alarm signalresponsively to a result of a test of the sterilizing filter membrane ifthe test indicates a disintegration of the sterilizing filter membrane.

According to twenty-eighth embodiments, the disclosed subject matterincludes a fluid circuit for peritoneal dialysis and dialysatepreparation. A disposable mixing container of polymeric material has apre-attached fluid circuit, the mixing container and fluid circuit beingsealed from an external environment. The fluid circuit includes a fluidmultiplexer that has junctions and valve portions that mechanicallyinterface with valve actuators to define selectable flow paths in thefluid circuit. The fluid circuit includes at least two concentrate linesterminated by respective concentrate line connectors, a water lineterminated by a water line connector, and one or more lines connected topermit flow into and out of the mixing container. Each of theconcentrate and water lines has a testable inline sterilizing filter ora redundant serially-connected pair of sterilizing filters. The fluidcircuit has a pumping portion.

In variations thereof, the twenty-eighth embodiments include ones inwhich the testable inline sterilizing filters each have air lines thatare each collinear with at least a portion of a respective one of theconcentrate and water lines. In variations thereof, the twenty-eighthembodiments include ones in which the testable inline sterilizingfilters each have air lines that are each integral with at least aportion of a respective one of the concentrate and water lines. Invariations thereof, the twenty-eighth embodiments include ones thatinclude a rigid manifold chamber with pressure sensors integratedtherein, one at each end of a pumping tube segment of the pumpingportion. In variations thereof, the twenty-eighth embodiments includeones in which the pumping tube segment is straight. In variationsthereof, the twenty-eighth embodiments include ones in which the rigidmanifold has two separate chambers and the pressure sensor includes apressure pod with a diaphragm that serves as a portion of a wall of arespective one of the two separate chambers. In variations thereof, thetwenty-eighth embodiments include ones in which the respectiveconcentrate line connectors are connected by a frame that supportportions of the concentrate lines. In variations thereof, thetwenty-eighth embodiments include ones in which the frame has a windowand the portions of the concentrate lines pass across the window. Invariations thereof, the twenty-eighth embodiments include ones in whichthe fluid circuit has a drain line. In variations thereof, thetwenty-eighth embodiments include ones in which the drain and waterlines connected by a frame that support portions of the drain and waterlines. In variations thereof, the twenty-eighth embodiments include onesin which the frame has a window and portions of the drain and waterlines pass across the window. In variations thereof, the twenty-eighthembodiments include ones in which the valve portions are supported by aplanar element. In variations thereof, the twenty-eighth embodimentsinclude ones in which the planar element includes a pair of sheetsshaped to hold the valve portions in predefined positions. In variationsthereof, the twenty-eighth embodiments include ones in which the planarelement includes a pair of sheets shaped to hold the valve portions inpredefined positions, at least one of the pair of sheets having holes init to permit valve actuators to contact the valve portions. Invariations thereof, the twenty-eighth embodiments include ones in whichthe valve portions are tube segments. In variations thereof, thetwenty-eighth embodiments include ones in which the valve portions aretube segments.

In variations thereof, the twenty-eighth embodiments include ones inwhich the fluid circuit is held by a cartridge that includes parallelpanels with the valve portions sandwiched between them, at least twofrangible seals being held in the cartridge aligned with windows in atleast one of the panels to permit an actuator to fracture them prior touse thereby allowing the concentrate to flow through the at least twoconcentrate lines.

According to twenty-ninth embodiments, the disclosed subject matterincludes a method of making a peritoneal dialysis fluid includingdrawing a concentrate and water through a sterilizing filter inpredefined quantities and proportioning the concentrate and water tomake a sufficient quantity of peritoneal dialysis fluid for at least asingle fill of a peritoneal dialysis treatment. The drawing includes,using an interconnection module, connecting water and concentrate atdifferent times to a common inlet of a disposable fluid circuit to whichthe sterilizing filter is integrally attached and testing thesterilizing filter by an air pressure test and using, or preventing useof, the quantity for a peritoneal dialysis fill and drain cycledepending on a result of the testing.

In variations thereof, the twenty-ninth embodiments include ones inwhich connecting a long-term concentrate container to theinterconnection module once every multiple peritoneal dialysistreatments. In variations thereof, the twenty-ninth embodiments includeones that include connecting a treatment circuit having the sterilizingfilter integrally attached thereto, to the interconnection module onceevery single peritoneal dialysis treatments. In variations thereof, thetwenty-ninth embodiments include ones that include mixing the water andthe concentrate. In variations thereof, the twenty-ninth embodimentsinclude ones in which the drawing and the mixing are performed using asingle common pump. In variations thereof, the twenty-ninth embodimentsinclude ones in which the disposable fluid circuit has at least oneconcentrate container that is initially empty and the drawing aconcentrate includes filling the at least one concentrate container withconcentrate. In variations thereof, the twenty-ninth embodiments includeones in which the proportioning includes transferring concentrate fromthe at least one concentrate container to a mixing container. Invariations thereof, the twenty-ninth embodiments include ones in whichthe proportioning includes transferring water through the common inletto a mixing container. In variations thereof, the twenty-ninthembodiments include ones in which the proportioning includestransferring concentrate from the at least one concentrate container toa mixing container and transferring water through the common inlet to amixing container.

According to thirtieth embodiments, the disclosed subject matterincludes a method of performing a peritoneal dialysis treatmentincluding drawing a concentrate and water through a sterilizing filterin predefined quantities to make a sufficient quantity of peritonealdialysate for a single fill of a peritoneal dialysis treatment. Thedrawing includes connecting water and concentrate at different times toa common inlet of a disposable fluid circuit to which the sterilizingfilter is integrally attached.

In variations thereof, the thirtieth embodiments include ones in whichthe sterilizing filters includes separate filter elements connected inseries by a flow channel. In variations thereof, the thirtiethembodiments include ones that include testing the sterilizing filter byan air pressure test and using, or preventing use of, the quantity for aperitoneal dialysis fill and drain cycle depending on a result of thetesting. In variations thereof, the thirtieth embodiments include onesthat include connecting a long term concentrate container to aninterconnection module once every multiple peritoneal dialysistreatments. In variations thereof, the thirtieth embodiments includeones that include connecting a treatment circuit having the sterilizingfilter integrally attached thereto, to the interconnection module onceevery single peritoneal dialysis treatments. In variations thereof, thethirtieth embodiments include ones that include mixing the water and theconcentrate. In variations thereof, the thirtieth embodiments includeones in which the drawing and the mixing are performed using a singlecommon pump.

According to thirty-first embodiments, the disclosed subject matterincludes a method of performing a peritoneal dialysis treatmentincluding drawing a concentrate and water through respective sterilizingfilters in predefined quantities to make a sufficient quantity ofperitoneal dialysate for a single fill of a peritoneal dialysistreatment. The drawing includes, using an interconnection module,flowing water and concentrate in succession to a mixing container theflowing water and concentrate in succession including switching flowpaths in a peritoneal dialysis cycler. The method includes ensuring anintegrity of the respective sterilizing filters by testing them orproviding the respective sterilizing filters as serially-connectedredundant sterilizing filter elements.

In variations thereof, the thirty-first embodiments include ones thatinclude connecting a long term concentrate container to theinterconnection module once every multiple peritoneal dialysistreatments. In variations thereof, the thirty-first embodiments includeones that include connecting a treatment circuit having the respectivesterilizing filters integrally attached thereto, to the interconnectionmodule once every single peritoneal dialysis treatments. In variationsthereof, the thirty-first embodiments include ones that include mixingthe water and the concentrate. In variations thereof, the thirty-firstembodiments include ones in which the drawing and the mixing areperformed using a single common pump. In variations thereof, thethirty-first embodiments include ones in which the connecting atreatment circuit includes removing at least one sterile seal from waterand concentrate connectors and connecting one or more new connectors ofthe treatment circuit to water and concentrate connectors and whereinfollowing the using the quantity, cutting one or more portions of theone or more new connectors to create at least one new sterile seal. Invariations thereof, the thirty-first embodiments include ones in whichthe interconnection module supports a connector of the concentratecontainer, the connecting a long term concentrate connector includingreplacing the connector of the concentrate container and the connectinga treatment circuit includes connecting the treatment circuit to theconnector of the concentrate container. In variations thereof, thethirty-first embodiments include ones in which the flowing water andconcentrate in succession using the interconnection module includeswashing a fixed volume of concentrate from a common outlet of theinterconnection module and an inlet of a disposable fluid circuit, themethod further comprising, using a controller used to make thesufficient quantity, calculating an amount of the fixed volume andcontrolling an amount of water pumped to form the sufficient quantityresponsively to a result of the calculating.

According to thirty-second embodiments, the disclosed subject matterincludes a system for preparation of sterile medical treatment fluid. Adisposable fluid circuit has a pumping tube segment and multiple valvesegments. A proportioning and treatment device has at least one pumpingactuator positioned to engage the at least one pumping tube segment andmultiple valve actuators positioned to engage the multiple valvesegments. A first of the multiple valve segments is connected to a fluidinlet. The disposable fluid circuit has a sterilizing filter connectedbetween a fluid inlet connector and the first of the multiple valvesegments. A first concentrate container has sufficient concentrate forpreparation of enough peritoneal dialysate to perform multipleperitoneal dialysis treatments, each treatment including multiplefill/drain cycles. The disposable fluid circuit having anintegrally-attached mixing container sized to hold sufficient peritonealdialysate for at least a single fill/drain cycle. An interconnectionmodule has a primary concentrate connector and a primary waterconnector, to which the first concentrate container is connected onceevery multiple treatments. The interconnection module also has a commonsecondary connector to which the disposable fluid circuit fluid inletconnector is connected once every treatment. The interconnection modulehas a valve network controlled by a programmable controller that selectswater or concentrate to flow through the common secondary connector. Theproportioning and treatment device has a programmable controllerprogrammed to control the at least one pumping actuator to pumpconcentrate and water into the mixing container to make a batch ofperitoneal dialysate and subsequently to perform a fill/drain cycleincluding draining spent peritoneal dialysate and pumping a fill of theperitoneal dialysate from the mixing container.

In variations thereof, the thirty-third embodiments include ones thatinclude a controller, the controller being programmed to calculate andstore data representing a volume of water or concentrate remaining in aportion of the valve network after selecting water or concentrate to bedrawn by the proportioning and treatment device and to control the pumpresponsively to the data representing a volume of water or concentrate.

According to thirty-fourth embodiments, the disclosed subject matterincludes a method of making a fluid circuit having a chamber prefilledwith medicament concentrate. The method includes integrally connecting afluid circuit with a chamber and connecting a sterilizing filter withthe chamber. The integrally connecting and connecting a sterilizingfilter forms an assembly with a sealed volume that is separated from anoutside environment by walls thereof, a frangible plug in a concentrateoutlet line stemming from the chamber, and a membrane of the sterilizingfilter. The method includes sterilizing the assembly. The methodincludes sterile-filling the chamber with concentrate through thesterilizing filter. The method includes permanently sealing and thencutting a line connecting the sterilizing filter and the chamber andsubjecting the fluid circuit and chamber to gamma or e-beamsterilization.

According to thirty-fifth embodiments, the disclosed subject matterincludes a method of making a fluid circuit having a chamber prefilledwith medicament concentrate. The method includes integrally connecting afluid circuit with a chamber. The method includes connecting asterilizing filter with the chamber. The integrally connecting andconnecting a sterilizing filter form an assembly with a sealed volumethat is separated from an outside environment by walls thereof, afrangible plug in a concentrate outlet line stemming from the chamber,and a membrane of the sterilizing filter. The method includessterilizing the assembly. The method includes sterile-filling thechamber with concentrate through the sterilizing filter. The methodincludes heat welding and cutting a line connecting the sterilizingfilter and the chamber and subjecting the fluid circuit and chamber togamma or e-beam sterilization.

According to thirty-fifth embodiments, the disclosed subject matterincludes a fluid line connector with at least one thermoplastic tubesupported in a frame such that the at least one thermoplastic tube isaccessible from opposite sides of the frame. The frame has anoverhanging ridge at one end and at least one connector that is fluidlycoupled at an opposite end to the at least one thermoplastic tube. A capis fitted to the frame to cover the at least one connector. The at leastone tube extends through holes in the frame at end thereof adjacent theoverhanging ridge.

In variations thereof, the thirty-fifth embodiments include ones inwhich the frame has a recess shaped to engage a détente pin along anelongate side thereof. In variations thereof, the thirty-fifthembodiments include ones in which the frame has an oval-shaped recess,the at least one connector being located within the oval-shaped recess.In variations thereof, the thirty-fifth embodiments include ones inwhich the cap fits in the oval-shaped recess to define a tortuous pathbetween the at least one connector and an access of the oval-shapedrecess. In variations thereof, the thirty-fifth embodiments include onesin which at least one connector and the at least one thermoplastic tubesare at least two.

According to thirty-sixth embodiments, the disclosed subject matterincludes a connector system. A connector component has at least onethermoplastic tube supported in a frame such that the at least onethermoplastic tube is accessible from opposite sides of the frame. Theframe has an overhanging ridge at one end and at least one connectorthat is fluidly coupled at an opposite end to the at least onethermoplastic tube. A cap is fitted to the frame to cover the at leastone connector. The at least one tube extends through holes in the frameat an end thereof adjacent the overhanging ridge. A fluid supply devicehas at least one supply connector that mates with the at least oneconnector, the fluid supply device having a portion shaped to engage theframe to align the at least one thermoplastic tube with a tubecut-and-seal device.

In variations thereof, the thirty-sixth embodiments include ones inwhich the cut-and-seal device cuts the at least one thermoplastic tubeand seals it at both ends, the connector component being configured topermit the at least one thermoplastic tube to be withdrawn from the oneend leaving the frame and at least one connector in place on the atleast one supply connector to cover and protect it from contaminationuntil it is replaced by another connector component. In variationsthereof, the thirty-sixth embodiments include ones in which the framehas a recess shaped to engage a détente pin along an elongate sidethereof. In variations thereof, the thirty-sixth embodiments includeones in which the frame has an oval-shaped recess, the at least oneconnector being located within the oval-shaped recess. In variationsthereof, the thirty-sixth embodiments include ones in which the cap fitsin the oval-shaped recess to define a tortuous path between the at leastone connector and an access of the oval-shaped recess. In variationsthereof, the thirty-sixth embodiments include ones in which at least oneconnector and the at least one thermoplastic tubes are at least two. Invariations thereof, the thirty-sixth embodiments include ones in whichthe frame has a recess shaped to engage a détente pin along an elongateside thereof. In variations thereof, the thirty-sixth embodimentsinclude ones in which the frame has an oval-shaped recess, the at leastone connector being located within the oval-shaped recess.

In variations thereof, the thirty-sixth embodiments include ones inwhich the cap fits in the oval-shaped recess to define a tortuous pathbetween the at least one connector and an access of the oval-shapedrecess. In variations thereof, the thirty-sixth embodiments include onesin which at least one connector and the at least one thermoplastic tubesare at least two.

According to thirty-seventh embodiments, the disclosed subject matterincludes a fluid proportioning system with first and second manifoldsconnected by a pump. A port on the first manifold is provided forconnection of a last-fill medicament and/or an auxiliary fluid. Acontroller is programmed to control the pump to draw, according to acommand generated by the controller, a last fill or an auxiliary fluid.

In variations thereof, the thirty-seventh embodiments include ones thatinclude a mixing container, the controller being programmed to transferthe auxiliary fluid to the mixing container and to use contents thereofto fill a peritoneum. In variations thereof, the thirty-seventhembodiments include ones in which the controller fills the mixingcontainer with a fill of peritoneal dialysate prior to controlling thepump to draw a last fill or an auxiliary fluid. In variations thereof,the thirty-seventh embodiments include ones in which the controller isprogrammed to use contents of the mixing container to perform aperitoneal dialysis treatment.

According to thirty-eighth embodiments, the disclosed subject matterincludes a method of mixing a medicament, the method including using acontroller, combining respective quantities of water and liquid firstmedicament concentrate in a first target concentration calculated by thecontroller responsively to a map of allowed and disallowed ratios and afinal prescribed concentration of the first medicament to generate aninitial mixture. The method includes using the controller, testing theconcentration of the initial mixture including measuring a conductivityof thereof. The method includes using the controller, responsively tothe testing, diluting the initial mixture to a second targetconcentration of first medicament and further testing the concentrationof a resulting second mixture including measuring a conductivitythereof.

In variations thereof, the thirty-eighth embodiments include ones thatinclude, using the controller, adding a second medicament concentrate tothe second mixture.

In variations thereof, the thirty-eighth embodiments include ones inwhich the first target is based on an optimization of total pumping timeto minimize the time it to prepare a completed mixed batch ofmedicament.

According to thirty-ninth embodiments, the disclosed subject matterincludes a system for making a peritoneal dialysis fluid. The systemincludes a peritoneal dialysis system component connectable to first andsecond containers of first and second concentrates and a water sourceand a disposable fluid circuit with a pumping portion and a mixingcontainer. The system includes pumping and valve actuators controlled bya controller, which controls them to engage the disposable fluid circuitto create a predefined mixture of water, a first concentrate, and asecond concentrate to form a ready-to-use peritoneal dialysate by:

(a) pumping a first quantity of water into the mixing container;

(b) pumping an amount of the first concentrate into the mixing containerestimated to achieve a target conductivity of contents of the mixingcontainer;

(c) testing a conductivity of the mixing container contents and,responsively to a result of the testing, adjusting a target amount ofwater and a target amount of a second concentrate to add to the mixingcontainer if a result of the testing indicates a conductivity above thetarget conductivity;

(d) outputting an indication of a failed in-process mixture if theconductivity is below the target conductivity;

(e) adding an adjusted target amount of water and an adjusted targetamount of second concentrate to the mixing container; and

(f) testing a conductivity of contents of the mixing container anddepending on a result of the testing, outputting an indication of asuccessful or failed in-process mixture.

In variations thereof, the thirty-ninth embodiments include ones inwhich, after the adding an adjusted target amount of water, testing aconductivity of the contents of the mixing container and adding afurther amount of water if a conductivity resulting from the testing ishigher than a target. In variations thereof, the thirty-ninthembodiments include ones in which an amount of water added by the addinga further amount of water is responsive to the conductivity resultingfrom the testing.

According to fortieth embodiments, the disclosed subject matter includesa method of forming a batch of treatment fluid. The method includesadding water to a mixing container. The method includes adding a firstconcentrate to the mixing container and testing a conductivity of itscontents. The method includes outputting an indication of a failed batchin the mixing container if the conductivity is below a first predefinedlevel. The method includes, responsively to the conductivity,calculating an additional quantity of water and an additional quantityof a second concentrate to be added to the mixing container if theconductivity is above the predefined level. The method includes addingwater and the second concentrate, including the additional quantities,to the mixing container.

In variations thereof, the fortieth embodiments include ones thatinclude testing the conductivity of the mixing container contents andresponsively to the conductivity outputting an indication of a failedbatch in the mixing container if the conductivity is below a secondpredefined level.

According to forty-first embodiments, the disclosed subject matterincludes a method of preparing a batch of treatment fluid. The methodincludes adding a quantity of an osmotic agent to a mixing containercontaining an electrolyte and detecting quantity of the added osmoticagent by a reduction in a conductivity of a solution in the mixingcontainer.

In variations thereof, the forty-first embodiments includes ones thatinclude adjusting a concentration of water or electrolyte responsivelyto a result of the detecting in order to achieve a target mixture ofelectrolyte and osmotic agent.

According to forty-second embodiments, the disclosed subject matterincludes a method of preparing a batch of treatment fluid. The methodincludes

adding a fraction of a final quantity of water plus a first concentrateto a mixing container;

mixing the contents of the mixing container and testing a firstconductivity of the contents;

if the first conductivity is below a first predefined range, outputtingan indication of a failure of the mixing container contents;

if the first conductivity is above the first predefined range,calculating a first additional amount of water, to add to the finalquantity, responsive to the first conductivity, plus an additionalquantity beyond a final quantity of a second concentrate and add thesecond concentrate to the mixing container;

if the first conductivity is in the first predefined range, add thesecond concentrate to the mixing container;

adding a remainder of the final quantity of water plus the additionalamount of water, if calculated, to the mixing container;

mixing the contents of the mixing container and testing a secondconductivity of the contents;

if the second conductivity is below a second predefined range,outputting an indication of a failure of the mixing container contents;and

if the second conductivity is within the second predefined range, makingthe contents of the mixing container available for a treatment.

In variations thereof, the forty-second embodiments include ones inwhich, if the second conductivity is above the second predefined range,adding the first additional amount of water plus a second additionalamount of water responsive to the second conductivity. In variationsthereof, the forty-second embodiments include ones that include usingthe contents of the mixing container for a dialysis treatment. Invariations thereof, the forty-second embodiments include ones thatinclude using the contents of the mixing container for a peritonealdialysis treatment.

According to forty-third embodiments, the disclosed subject matterincludes method of making a batch of peritoneal dialysis fluid. Themethod includes:

(a) adding a first amount of water to a mixing container that is lessthan required to make the batch of peritoneal dialysis fluid;

(b) adding a first concentrate to the mixing container, mixing themixing container contents, measuring a resulting first conductivity ofthe mixing container contents, and determining if the first conductivityis in a first range;

(c) if the first conductivity is in the first range, adding a secondconcentrate to the mixing container, mixing the mixing containercontents, and measuring a resulting second conductivity of the mixingcontainer contents;

(d) if the second conductivity is in a second range, adding water to themixing container, mixing and measuring a resulting third conductivity ofthe mixing container contents;

(e) if the third conductivity falls in a third range, generating asignal indicating the contents of the mixing container form a usablebatch of peritoneal dialysis fluid;

(f) if the first conductivity is outside the first range, calculating anamount of water or first concentrate responsively to the firstconductivity and an estimated quantity of fluid in the mixing containerand adding the amount of water or first concentrate to the mixingcontainer, mixing the mixing container contents, and measuring aresulting fourth conductivity of the mixing container contents;

(g) if the fourth conductivity is in the first range, adding the secondconcentrate to the mixing container, mixing the mixing containercontents, and measuring a resulting fifth conductivity of the mixingcontainer contents;

(h) if the fifth conductivity is in the second range, adding water tothe mixing container, mixing the mixing container contents, measuring aresulting sixth conductivity of the mixing container;

(i) if the sixth conductivity is in the third range, generating a signalindicating the contents of the mixing container form a usable batch ofperitoneal dialysis fluid; and

(j) if the second conductivity is outside the second range, the thirdconductivity is outside the third range, the fourth conductivity isoutside the first range, the fifth conductivity is outside the secondrange, or the sixth conductivity is outside the third range, generatinga signal indicating to terminate the making of a batch.

In variations thereof, the forty-third embodiments include ones in whichthe first concentrate is electrolyte concentrate and the secondconcentrate is osmotic agent concentrate. In variations thereof, theforty-third embodiments include ones in which the first concentrate isosmotic agent concentrate and the second concentrate is electrolyteconcentrate.

According to forty-fourth embodiments, the disclosed subject matterincludes a method for making a batch of peritoneal dialysis fluid. Themethod includes:

(a) adding water to a mixing container;

(b) adding electrolyte concentrate to the mixing container;

(c) mixing contents of the mixing container and measuring theconductivity of its contents;

(d) if the conductivity measured at (c) is in a first range, performingstep (h) and if the conductivity measured at (c) is outside the firstrange performing step (e);

(e) estimating an amount of water or electrolyte concentrate,responsively to the conductivity measured in step (c), to bring theconductivity of the contents of the mixing container within the firstrange;

(f) adding the amount of water estimated in (e) to the mixing container,mixing the contents of the mixing container, and measuring theconductivity of its contents;

(g) if the conductivity measured in step (f) is outside a second range,generating a command to abort the making of the batch and performingstep (p);

(h) calculating a quantity of a second concentrate according to apredefined ratio of the first and second concentrates responsively to acalculated quantity of fluid held by the mixing container and theconductivity measured at step (d) if the conductivity measured at step(c) was in the first range or the conductivity measured at (f) if not;

(i) adding the quantity of the second concentrate calculated at step (h)to the mixing container, mixing the contents of the mixing container,and measuring the conductivity thereof;

(j) if the conductivity measured at step (i) is outside the secondrange, generating a command to abort the making of the batch and goingto step (p);

(k) if the conductivity measured at step (i) is in the second range,then calculating a quantity of water to add to the mixing containerresponsively to the conductivity measured at step (i) and a calculatedquantity of fluid held by the mixing container;

(m) adding the quantity of water calculated at step (k) to the mixingcontainer, mixing the contents of the mixing container, and measuringthe conductivity of its contents;

(n) if the conductivity measured at step (m) falls in a third range,generating a command indicating the mixing container contents areusable;

(o) if the conductivity measured at step (m) fall outside the thirdrange, generating a command to abort the making of the batch; and

(p) terminating the method.

In variations thereof, the forty-fourth embodiments include ones inwhich the first concentrate is electrolyte concentrate and the secondconcentrate is osmotic agent concentrate. In variations thereof, theforty-fourth embodiments include ones in which the first concentrate isosmotic agent concentrate and the second concentrate is electrolyteconcentrate. In variations thereof, the forty-fourth embodiments includeones in which a quantity of the adding electrolyte at step (b) isresponsive to an estimate of an amount required for a completed batch.In variations thereof, the forty-fourth embodiments include ones inwhich each of the measuring the conductivity includes draining a portionof the contents of the mixing container. In variations thereof, theforty-fourth embodiments include ones in which the quantity of theadding electrolyte at step (b) is responsive to an estimate of aquantity of every instance of draining a portion.

According to forty-fifth embodiments, the disclosed subject matterincludes a method of preparing a batch of treatment fluid. The methodincludes adding a quantity of an osmotic agent to a mixing containercontaining an electrolyte and detecting quantity of the added osmoticagent by a reduction in a conductivity of a solution in the mixingcontainer.

In variations thereof, the forty-fifth embodiments include ones in whichadjusting a concentration of water or electrolyte responsively to aresult of the detecting in order to achieve a target mixture ofelectrolyte and osmotic agent.

According to forty-sixth embodiments, the disclosed subject matterincludes a method of performing a peritoneal dialysis treatment. Themethod includes performing a fill cycle of a peritoneal dialysistreatment. The method includes performing a drain cycle of a peritonealdialysis treatment and during the drain cycle, diverting at least onefraction of spent peritoneal dialysis fluid to a sample container tocollect a sample.

In variations thereof, the forty-sixth embodiments include ones in whichthe sample includes multiple fractions of spent peritoneal dialysisdiverted at different times during the drain cycle. In variationsthereof, the forty-sixth embodiments include ones in which the differenttimes, stored in a controller, are calculated to make the samplerepresentative of the composition of all of the spent peritonealdialysis fluid of a full drain cycle. In variations thereof, theforty-sixth embodiments include ones in which the diverting includesfilling a container of less than 500 ml. In variations thereof, theforty-sixth embodiments include ones that include, using a controller,outputting instructions for handling the sample container. In variationsthereof, the forty-sixth embodiments include ones that include, using acontroller, outputting instructions for handling the sample container.In variations thereof, the forty-sixth embodiments include ones thatinclude, using a controller, outputting instructions for removing,sealing, and delivering a sample collected in the sample container.

According to forty-seventh embodiments, the disclosed subject matterincludes a method of performing a peritoneal dialysis treatment. Themethod includes using a controller, during a peritoneal dialysis draincycle, according to a schedule of fractioning times stored in acontroller, diverting fractions of spent peritoneal dialysis fluid fromspent peritoneal dialysis fluid to a sample container. The schedule isresponsive to predicted variations in the composition of the spentperitoneal dialysis fluid during a drain cycle and the fractioning timesindicate times and durations of the fractions.

In variations thereof, the forty-seventh embodiments include ones inwhich the times and durations are independent of each other. Invariations thereof, the forty-seventh embodiments include ones in whichat least two of the durations are different from each other. Invariations thereof, the forty-seventh embodiments include ones thatinclude, diverting spent dialysis fluid other than the fractions to adrain responsively to the schedule.

According to forty-eighth embodiments, the disclosed subject matterincludes a method of performing a peritoneal dialysis treatment. Themethod includes, using a controller, performing multiple drain cyclesover the course of a peritoneal dialysis treatment and, for at least oneof the drain cycles, diverting one or more fractions of spent peritonealdialysis fluid from one or more of the multiple drain cycles and to arespective sample container for each of the multiple drain cycles. Themethod includes diverting one or more portions of the spent peritonealdialysis fluid other than the one or more fractions, to a drain or wastecollection container. The timings of the diverting of the one or morefractions are selected such that the resulting composition of thecontents of each sample represent a composition of all, or a portion, ofthe entire contents of a respective one of the drain cycles.

In variations thereof, the forty-eighth embodiments include ones thatinclude comparing the contents of one or more of the respective samplecontainers to a model that estimates the composition of all, or aportion, of the entire contents of a respective one of the drain cycles.In variations thereof, the forty-eighth embodiments include ones thatinclude accepting input from a user interface of the controllerindicating a total volume of the one or more fractions for each of theone or more of the multiple drain cycles, the controller using the inputto control the total volume during the peritoneal dialysis treatment. Invariations thereof, the forty-eighth embodiments include ones thatinclude accepting input from a user interface of the controllerindicating spacings of timings of the one or more fractions for each ofthe one or more of the multiple drain cycles, the controller using theinput to control the spacings of timings during the peritoneal dialysistreatment.

In variations thereof, the forty-eighth embodiments include ones inwhich the one or more fractions is a plurality of fractions, the methodfurther comprising accepting input from a user interface of thecontroller indicating a timing of a first of the plurality of fractionsfor each of the one or more of the multiple drain cycles, the controllerusing the input to control the timing of a first of the plurality offractions during the peritoneal dialysis treatment. In variationsthereof, the forty-eighth embodiments include ones in which the one ormore fractions is a single fraction, the method further comprisingaccepting input from a user interface of the controller indicating atiming of the single fraction for each of the one or more of themultiple drain cycles, the controller using the input to control thetiming of the single fraction during the peritoneal dialysis treatment.In variations thereof, the forty-eighth embodiments include ones thatinclude accepting input from a user interface of the controllerindicating a quantity of an initial one of the portions of the spentperitoneal dialysis other than the one or more fractions, the controllerusing the input to control the quantity of an initial one of theportions during the peritoneal dialysis treatment. In variationsthereof, the forty-eighth embodiments include ones that includeaccepting input from a user interface of the controller indicatingtreatment days on which to collect the one or more fractions andcorresponding combinations of parameters for each of the treatment daysto create a sampling schedule, the controller using the schedule tocontrol the collection of the one or more fractions according tocorresponding combinations of parameters over successive peritonealdialysis treatments.

In variations thereof, the forty-eighth embodiments include ones inwhich a user interface of the controller accepts input indicating amaximum number of reschedulings of days on which to collect the one ormore fractions, the method further comprising, using the controller,preventing input attempting to reschedule more than the maximum numberof days on which to collect the one or more fractions. In variationsthereof, the forty-eighth embodiments include ones in which a userinterface of the controller accepts input indicating a schedule of dayson which to collect the one or more fractions by date, day of week, dayof month, or number of times in a predefined interval, the methodfurther comprising, using the controller, controlling the days on whichthe one or more fractions are collected over successive peritonealdialysis treatments. In variations thereof, the forty-eighth embodimentsinclude ones in which the controller controls a number of the one ormore fractions per drain cycle, a number of sample containers to fillwith corresponding ones of the one or more fractions during a treatment,or a flow rate of draining, or any combination thereof, responsively toinput received from a user interface.

According to forty-ninth embodiments, the disclosed subject matterincludes a dialysis system. A dialysis device has a proportioningelement configured to generate dialysis fluid and a cycler to deliverdialysis fluid to a patient to perform dialysis therapy. The dialysisdevice further has a digital controller configured to direct a sequenceof operations for the therapy. The dialysis device further includes awireless interface configured to communicate with a wireless device orto write to or read from a data carrier including one of a near fieldcommunication (NFC) device and a radio frequency identification (RFID)device.

In variations thereof, the forty-ninth embodiments include ones in whichthe dialysis device is configured to upload a prescription for aperitoneal dialysis therapy through the wireless interface. Invariations thereof, the forty-ninth embodiments include ones in whichthe wireless interface is configured to transfer a digital record oftherapy data following a treatment to the wireless device. In variationsthereof, the forty-ninth embodiments include ones in which the wirelessinterface is configured to read a prescription or peritoneal dialysistherapy from the wireless device. In variations thereof, the forty-ninthembodiments include ones in which the wireless interface is configuredto read patient identifying information from a phone, a tablet, acomputer, NFC, or RFID device. In variations thereof, the forty-ninthembodiments include ones in which the wireless interface is configuredto read patient information from the wireless device. In variationsthereof, the forty-ninth embodiments include ones in which the wirelessinterface is configured to transfer system logging information to thewireless device. In variations thereof, the forty-ninth embodimentsinclude ones in which the wireless interface is configured to transferdiagnostic system logging information to the wireless device. Invariations thereof, the forty-ninth embodiments include ones in whichthe wireless device includes a phone, a tablet, and NFC device or anRFID device or a computer.

According to fiftieth embodiments, the disclosed subject matter includesa method of priming a dialysis fluid circuit. The method includespriming a dialysis fluid circuit with priming fluid using a pump havinga pumping tube segment and running the pump with priming fluid byrecirculating the priming fluid for a predetermined period of timebeyond that required for priming the dialysis fluid circuit.

In variations thereof, the fiftieth embodiments include ones in whichthe pump is a peristaltic pump. In variations thereof, the fiftiethembodiments include ones in which the predetermined period of time iseffective to break-in the pumping tube segment. In variations thereof,the fiftieth embodiments include ones in which the predetermined periodof time is determined based on an estimate of the time or number of pumprotations required to cause a relationship between pump cycles and flowrate to vary by less than a predetermined rate. In variations thereof,the fiftieth embodiments include ones in which the priming includesrecirculating priming fluid in a loop through the pumping tube segment.In variations thereof, the fiftieth embodiments include ones in whichthe predetermined period of time is determined responsive to an estimateof a relationship between pump cycles and flow rate to vary by less thana predetermined rate.

It will be appreciated that the modules, processes, systems, andsections described above can be implemented in hardware, hardwareprogrammed by software, software instruction stored on a non-transitorycomputer readable medium or a combination of the above. For example, amethod for preparing a treatment fluid and/or treating a patient can beimplemented, for example, using a processor configured to execute asequence of programmed instructions stored on a non-transitory computerreadable medium. For example, the processor can include, but not belimited to, a personal computer or workstation or other such computingsystem that includes a processor, microprocessor, microcontrollerdevice, or is comprised of control logic including integrated circuitssuch as, for example, an Application Specific Integrated Circuit (ASIC).The instructions can be compiled from source code instructions providedin accordance with a programming language such as Java, C++, C#.net orthe like. The instructions can also comprise code and data objectsprovided in accordance with, for example, the Visual Basic™ language,LabVIEW, or another structured or object-oriented programming language.The sequence of programmed instructions and data associated therewithcan be stored in a non-transitory computer-readable medium such as acomputer memory or storage device which may be any suitable memoryapparatus, such as, but not limited to read-only memory (ROM),programmable read-only memory (PROM), electrically erasable programmableread-only memory (EEPROM), random-access memory (RAM), flash memory,disk drive and the like.

Furthermore, the modules, processes, systems, and sections can beimplemented as a single processor or as a distributed processor.Further, it should be appreciated that the steps mentioned above may beperformed on a single or distributed processor (single and/ormulti-core). Also, the processes, modules, and sub-modules described inthe various figures of and for embodiments above may be distributedacross multiple computers or systems or may be co-located in a singleprocessor or system. Exemplary structural embodiment alternativessuitable for implementing the modules, sections, systems, means, orprocesses described herein are provided below.

The modules, processors or systems described above can be implemented asa programmed general purpose computer, an electronic device programmedwith microcode, a hard-wired analog logic circuit, software stored on acomputer-readable medium or signal, an optical computing device, anetworked system of electronic and/or optical devices, a special purposecomputing device, an integrated circuit device, a semiconductor chip,and a software module or object stored on a computer-readable medium orsignal, for example.

Embodiments of the method and system (or their sub-components ormodules), may be implemented on a general-purpose computer, aspecial-purpose computer, a programmed microprocessor or microcontrollerand peripheral integrated circuit element, an ASIC or other integratedcircuit, a digital signal processor, a hardwired electronic or logiccircuit such as a discrete element circuit, a programmed logic circuitsuch as a programmable logic device (PLD), programmable logic array(PLA), field-programmable gate array (FPGA), programmable array logic(PAL) device, or the like. In general, any process capable ofimplementing the functions or steps described herein can be used toimplement embodiments of the method, system, or a computer programproduct (software program stored on a non-transitory computer readablemedium).

It will be evident from the context that in many instances that a watersource may be, or include, a water purifier or a water filtrationsystem. See for example, water filtration system 551 in FIGS. 22Athrough 22C.

Furthermore, embodiments of the disclosed method, system, and computerprogram product may be readily implemented, fully or partially, insoftware using, for example, object or object-oriented softwaredevelopment environments that provide portable source code that can beused on a variety of computer platforms. Alternatively, embodiments ofthe disclosed method, system, and computer program product can beimplemented partially or fully in hardware using, for example, standardlogic circuits or a very-large-scale integration (VLSI) design. Otherhardware or software can be used to implement embodiments depending onthe speed and/or efficiency requirements of the systems, the particularfunction, and/or particular software or hardware system, microprocessor,or microcomputer being utilized. Embodiments of the method, system, andcomputer program product can be implemented in hardware and/or softwareusing any known or later developed systems or structures, devices and/orsoftware by those of ordinary skill in the applicable art from thefunction description provided herein and with a general basic knowledgeof control system, fluid handling systems, medical treatment and/orcomputer programming arts.

Moreover, embodiments of the disclosed method, system, and computerprogram product can be implemented in software executed on a programmedgeneral purpose computer, a special purpose computer, a microprocessor,or the like.

FIG. 14 shows a block diagram of an example computer system according toembodiments of the disclosed subject matter. In various embodiments, allor parts of system 1000 may be included in a medical treatmentdevice/system such as a renal replacement therapy system. In theseembodiments, all or parts of system 1000 may provide the functionalityof a controller of the medical treatment device/systems. In someembodiments, all or parts of system 1000 may be implemented as adistributed system, for example, as a cloud-based system.

System 1000 includes a computer 1002 such as a personal computer orworkstation or other such computing system that includes a processor1006. However, alternative embodiments may implement more than oneprocessor and/or one or more microprocessors, microcontroller devices,or control logic including integrated circuits such as ASIC.

Computer 1002 further includes a bus 1004 that provides communicationfunctionality among various modules of computer 1002. For example, bus1004 may allow for communicating information/data between processor 1006and a memory 1008 of computer 1002 so that processor 1006 may retrievestored data from memory 1008 and/or execute instructions stored onmemory 1008. In one embodiment, such instructions may be compiled fromsource code/objects provided in accordance with a programming languagesuch as Java, C++, C#, .net, Visual Basic™ language, LabVIEW, or anotherstructured or object-oriented programming language. In one embodiment,the instructions include software modules that, when executed byprocessor 1006, provide renal replacement therapy functionalityaccording to any of the embodiments disclosed herein.

Memory 1008 may include any volatile or non-volatile computer-readablememory that can be read by computer 1002. For example, memory 1008 mayinclude a non-transitory computer-readable medium such as ROM, PROM,EEPROM, RAM, flash memory, disk drive, etc. Memory 1008 may be aremovable or non-removable medium.

Bus 1004 may further allow for communication between computer 1002 and adisplay 1018, a keyboard 1020, a mouse 1022, and a speaker 1024, eachproviding respective functionality in accordance with variousembodiments disclosed herein, for example, for configuring a treatmentfor a patient and monitoring a patient during a treatment.

Computer 1002 may also implement a communication interface 1010 tocommunicate with a network 1012 to provide any functionality disclosedherein, for example, for alerting a healthcare professional and/orreceiving instructions from a healthcare professional, reportingpatient/device conditions in a distributed system for training a machinelearning algorithm, logging data to a remote repository, etc.Communication interface 1010 may be any such interface known in the artto provide wireless and/or wired communication, such as a network cardor a modem.

Bus 1004 may further allow for communication with a sensor 1014 and/oran actuator 1016, each providing respective functionality in accordancewith various embodiments disclosed herein, for example, for measuringsignals indicative of a patient/device condition and for controlling theoperation of the device accordingly. For example, sensor 1014 mayprovide a signal indicative of a viscosity of a fluid in a fluid circuitin a renal replacement therapy device, and actuator 1016 may operate apump that controls the flow of the fluid responsively to the signals ofsensor 1014.

It is, thus, apparent that there is provided, in accordance with thepresent disclosure, methods, devices, and system for preparing fluids,managing fluids, sterilizing fluids, treating patients and otherfunctions. Many alternatives, modifications, and variations are enabledby the present disclosure. Features of the disclosed embodiments can becombined, rearranged, omitted, etc., within the scope of the inventionto produce additional embodiments. Furthermore, certain features maysometimes be used to advantage without a corresponding use of otherfeatures. Accordingly, Applicants intend to embrace all suchalternatives, modifications, equivalents, and variations that are withinthe spirit and scope of the present invention.

What is claimed is:
 1. A method for making a peritoneal dialysis fluid,comprising: connecting a first fluid circuit to a proportioning machine,the first fluid circuit including a mixing container integrally attachedto the first fluid circuit and that is empty before the connecting, awater inlet connector, two or more concentrate inlet connectors, andempty low-capacity concentrate containers, the proportioning machinehaving actuators that engage with the first fluid circuit when receivedthereby; connecting a water source to the water inlet connector of thefirst fluid circuit; connecting two or more containers of concentrate tothe two or more concentrate inlet connectors of the first fluid circuit,each of said two or more containers of concentrate having sufficientconcentrate for making the peritoneal dialysis fluid for multipleperitoneal dialysis treatments, where one peritoneal dialysis treatmentincludes one or more fill cycles that fill a peritoneal cavity with theperitoneal dialysis fluid and corresponding drain cycles that drain theperitoneal dialysis fluid from the peritoneal cavity; filling the emptylow-capacity concentrate containers included in the first fluid circuitwith concentrate from the two or more containers of concentrate; using acontroller of the proportioning machine, flowing purified water from thewater source through the water inlet connector and concentrate from thetwo or more containers of concentrate through the two or moreconcentrate inlet connectors and through the first fluid circuit to themixing container of the first fluid circuit to prepare the peritonealdialysis fluid in said mixing container by proportioning the purifiedwater and the concentrate, wherein the flowing includes flowing thepurified water and the concentrate through at least one sterilizingfilter to ensure sterility of the purified water and the concentrate;using the controller, performing a peritoneal dialysis treatment on apatient using the peritoneal dialysis fluid from said mixing container,said peritoneal dialysis treatment including multiple fill cycles andcorresponding drain cycles; after performing the peritoneal dialysistreatment, replacing the first fluid circuit with a second fluid circuitthat is identical to the first fluid circuit and includes its own mixingcontainer, water inlet connector, and two or more concentrate inletconnectors, the replacing including disconnecting the first fluidcircuit from the proportioning machine, disconnecting the water inletconnector of the first fluid circuit from the water source, anddisconnecting the two or more concentrate inlet connectors of the firstfluid circuit from the two or more containers of concentrate; connectingthe second fluid circuit to the proportioning machine, connecting thewater inlet connector of the second fluid circuit to the water source,and connecting the two or more concentrate inlet connectors of thesecond fluid circuit to the two or more containers of concentrate; afterthe replacing, using the controller of the proportioning machine,flowing the purified water through the water inlet connector of thesecond fluid circuit and the concentrate from the two or more containersof concentrate through the two or more concentrate inlet connectors ofthe second fluid circuit and through the second fluid circuit to themixing container of the second fluid circuit to prepare a second batchof the peritoneal dialysis fluid in the mixing container of the secondfluid circuit; and treating the patient using the second batch of theperitoneal dialysis fluid from the mixing container of the second fluidcircuit, without replacing said two or more containers of concentrate,whereby the two or more containers of concentrate are replaced once forevery multiple replacements of fluid circuits.
 2. The method of claim 1,wherein said at least one sterilizing filter is integrally attached tosaid first fluid circuit.
 3. The method of claim 2, wherein said flowingthe purified water and the concentrate through at least one sterilizingfilter includes flowing the purified water and the concentrate throughseparate filters.
 4. The method of claim 1, wherein the flowing thepurified water includes pumping said purified water by a pump of thewater source.
 5. A treatment method, comprising: connecting a fluidcircuit to a proportioning machine, the fluid circuit including anintegrally attached mixing container that is empty before theconnecting, empty low-capacity concentrate containers, and one or moreconcentrate inlet connectors, the proportioning machine having actuatorsthat engage with the fluid circuit when received thereby; connecting oneor more containers of medicament concentrate through the one or moreconcentrate inlet connectors to the fluid circuit, each container of theone or more containers having sufficient medicament concentrate togenerate a medicament for multiple treatments of a patient, where onetreatment includes one or more fill cycles that fill a peritoneal cavitywith the medicament and corresponding drain cycles that drain themedicament from the peritoneal cavity; filling the empty low-capacityconcentrate containers included in the fluid circuit with medicamentconcentrate from the one or more containers of medicament concentrate;using the proportioning machine, flowing purified water and flowing themedicament concentrate through the one or more concentrate inletconnectors and through the fluid circuit to the mixing container toprepare the medicament in the mixing container by proportioning thepurified water and the medicament concentrate, the flowing includingflowing the purified water and the medicament concentrate through atleast one sterilizing filter to ensure sterility of the purified waterand of the medicament concentrate; ensuring an integrity of the at leastone sterilizing filter by testing the at least one sterilizing filter orproviding serially-connected redundant sterilizing filters; treating thepatient using the medicament prepared in the mixing container; andreplacing the fluid circuit with a new fluid circuit that is identicalto the fluid circuit and includes its own mixing container and repeatingthe connecting with the new fluid circuit, flowing the purified waterand the medicament concentrate, treating the patient using the new fluidcircuit, without replacing said one or more containers of medicamentconcentrate.
 6. The method of claim 5, wherein said at least onesterilizing filter is integrally attached to said fluid circuit.
 7. Themethod of claim 5, wherein said flowing the purified water and themedicament concentrate through at least one sterilizing filter includesflowing the purified water and the medicament concentrate throughseparate filters.
 8. The method according to claim 1, wherein the atleast one sterilizing filter includes serially-connected redundantsterilizing filters.
 9. The method according to claim 1, furthercomprising: using said controller, testing integrity of a membrane ofthe at least one sterilizing filter; and preventing a use of contents ofthe mixing container of the first fluid circuit responsively to a resultindicating failure of the integrity of the membrane.
 10. The methodaccording to claim 1, further comprising: pumping the concentrate fromthe low-capacity concentrate containers that were filled by the filling,with a peristaltic pump, to a conductivity sensor in fluid communicationwith a drain line of the first fluid circuit.
 11. The method accordingto claim 5, further comprising: pumping the concentrate from thelow-capacity concentrate containers that were filled by the filling,with a peristaltic pump, to a conductivity sensor in fluid communicationwith a drain line of the fluid circuit.
 12. The method of claim 9wherein said at least one sterilizing filter includes a testable filterwith an air line, the method including, using the controller, applying apressure to the air line to test an ability of a wetted membrane of thetestable filter to withstand pressure and thereby indicate the integrityof the membrane.